ELTROMBOPAG ( DrugBank: Eltrombopag )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 60 | 再生不良性貧血 | 30 |
| 63 | 特発性血小板減少性紫斑病 | 80 |
| 65 | 原発性免疫不全症候群 | 2 |
| 284 | ダイアモンド・ブラックファン貧血 | 1 |
| 285 | ファンコニ貧血 | 1 |
60. 再生不良性貧血
臨床試験数 : 235 / 薬物数 : 381 - (DrugBank : 83) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 160
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05049668 (ClinicalTrials.gov) | October 2021 | 13/9/2021 | RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial | Long-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients | Severe Aplastic Anemia | Drug: ATGAM plus CsA with or without Eltrombopag | European Society for Blood and Marrow Transplantation | NULL | Enrolling by invitation | N/A | N/A | All | 197 | France | |
| 2 | ChiCTR2100043229 | 2021-02-22 | 2021-02-09 | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | Aplastic anemia | Durgs Group:Elrombopag combined with Cyclosporine; | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 85 | Both | Durgs Group:61; | Phase 2 | China |
| 3 | NCT04328727 (ClinicalTrials.gov) | November 4, 2020 | 9/3/2020 | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia | A Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS) | Severe Aplastic Anemia (SAA) | Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA) | Novartis Pharmaceuticals | NULL | Active, not recruiting | 6 Years | N/A | All | 36 | Phase 2 | China;Japan;Korea, Republic of;Taiwan |
| 4 | NCT04403321 (ClinicalTrials.gov) | July 1, 2020 | 21/5/2020 | Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia Patients | Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia Patients | Aplastic Anemia;Drug Effect | Drug: Tacrolimus;Drug: Placebo (for Tacrolimus);Drug: Cyclosporin A | Peking Union Medical College Hospital | NULL | Not yet recruiting | 16 Years | 80 Years | All | 60 | Phase 2 | China |
| 5 | NCT04304820 (ClinicalTrials.gov) | May 7, 2020 | 10/3/2020 | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Severe Aplastic Anemia | Drug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-Globulin | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 3 Years | N/A | All | 39 | Phase 2 | United States |
| 6 | NCT03988608 (ClinicalTrials.gov) | December 9, 2019 | 13/6/2019 | Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects. | A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic Anemia | Aplastic Anemia | Drug: Eltrombopag 25 mg | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | China |
| 7 | JPRN-jRCTs071190032 | 26/11/2019 | 21/10/2019 | W-JHS AA02 | Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 | aplastic anemia | 1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased. 2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6. 3. The dose of steroid is as follows: Day 1 - day 5: methylprednisolone 2 mg/kg/day Day 6: Methylprednisolone 1 mg/kg/day Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day Discontinuation after day 21 4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study). | Ishiyama Ken | NULL | Recruiting | >= 18age old | < 80age old | Both | 60 | Phase 2 | Japan |
| 8 | EUCTR2016-002814-29-IT (EUCTR) | 14/06/2019 | 24/05/2021 | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral ] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE Product Name: Eltrombopag Product Code: [ETB115] INN or Proposed INN: 00319301 Other descriptive name: Eltrombopag Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India | ||
| 9 | EUCTR2015-003166-91-GB (EUCTR) | 22/05/2019 | 05/07/2017 | A phase II dose escalation study: use of eltrombopag in pediatric patientswith severe aplastic anemia or recurrent aplastic anemia | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 10 | EUCTR2015-003166-91-NL (EUCTR) | 14/11/2018 | 08/08/2017 | A phase II dose escalation study: use of eltrombopag in pediatric patients with severe aplastic anemia or recurrent aplastic anemia | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Portugal;United States;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 11 | NCT03243656 (ClinicalTrials.gov) | December 20, 2017 | 2/8/2017 | Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia | Randomized Clinical Trial of the Use of & Cyclosporine in Children With Sever Idiopathic Aplastic Anemia | Eltrombopag | Drug: Eltrombopag | Assiut University | NULL | Completed | 1 Year | 18 Years | All | 20 | Phase 4 | Egypt |
| 12 | EUCTR2015-003166-91-PT (EUCTR) | 15/12/2017 | 13/07/2017 | A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia. | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 13 | NCT03025698 (ClinicalTrials.gov) | September 30, 2017 | 12/1/2017 | A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia | A Phase II, Open-label, Non-controlled, Intra-patient Dose-escalation Study to Characterize the Pharmacokinetics After Oral Administration of Eltrombopag in Pediatric Patients With Refractory, Relapsed or Treatment Naive Severe Aplastic Anemia or Recurrent Aplastic Anemia | Aplastic Anemia | Drug: Eltrombopag;Drug: hATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Active, not recruiting | 1 Year | 18 Years | All | 51 | Phase 2 | United States;Hong Kong;Portugal;Russian Federation;Thailand;United Kingdom;Netherlands |
| 14 | EUCTR2016-002814-29-HU (EUCTR) | 07/09/2017 | 05/07/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 15 | EUCTR2016-002814-29-NL (EUCTR) | 21/07/2017 | 29/03/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months. | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 16 | NCT02998645 (ClinicalTrials.gov) | May 11, 2017 | 4/11/2016 | Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia | SOAR, Interventional Phase II Single-arm Study to Assess Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First Line Therapy in Adult Patients With Severe Acquired Aplastic Anemia | Severe Aplastic Anemia | Drug: eltrombopag;Drug: Cyclosporine | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 54 | Phase 2 | Brazil;Hong Kong;India;Italy;Korea, Republic of;Mexico;Spain;Thailand;Turkey;Hungary;Netherlands |
| 17 | EUCTR2016-002814-29-ES (EUCTR) | 21/03/2017 | 16/12/2016 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of | ||
| 18 | NCT03413306 (ClinicalTrials.gov) | December 10, 2016 | 22/12/2017 | Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA | A Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic Anemia | Acquired Aplastic Anemia | Drug: Eltrombopag;Drug: IST (ATG + CsA) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | 2 Years | 18 Years | All | 100 | Phase 3 | Russian Federation |
| 19 | EUCTR2014-000363-40-NL (EUCTR) | 07/01/2016 | 01/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Spain;Netherlands | ||
| 20 | EUCTR2014-000363-40-ES (EUCTR) | 26/10/2015 | 07/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Spain | |||
| 21 | NCT02099747 (ClinicalTrials.gov) | July 2015 | 6/3/2014 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients. | Severe Aplastic Anemia | Drug: hATG;Drug: CsA;Drug: Eltrombopag | European Group for Blood and Marrow Transplantation | Novartis;Pfizer | Active, not recruiting | 15 Years | N/A | All | 202 | Phase 3 | France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany |
| 22 | NCT02404025 (ClinicalTrials.gov) | May 12, 2015 | 26/2/2015 | Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects | A Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic Anemia Who Have Not Received Prior ATG/Anti-lymphocyte Globulin (ALG)-Based Immunosuppressive Therapy | Aplastic Anemia | Drug: Eltrombopag;Drug: Rabbit ATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | Japan |
| 23 | EUCTR2014-000174-19-DE (EUCTR) | 27/01/2015 | 01/09/2014 | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA | Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade 75 mg Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag Other descriptive name: ELTROMBOPAG OLAMINE | Universitätsklinikum Ulm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;Netherlands;Germany;Italy;Switzerland | ||
| 24 | NCT02773225 (ClinicalTrials.gov) | January 27, 2015 | 29/2/2016 | Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA) | Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter Study | Anemia, Aplastic | Drug: Eltrombopag;Drug: Placebo (for Eltrombopag) | B. Höchsmann | NULL | Recruiting | 18 Years | N/A | All | 116 | Phase 2/Phase 3 | Germany |
| 25 | NCT02148133 (ClinicalTrials.gov) | July 23, 2014 | 22/5/2014 | A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia | A Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia | Cytopaenia | Drug: Eltrombopag 12.5 mg;Drug: Eltrombopag 25 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 79 Years | All | 21 | Phase 2 | Japan |
| 26 | NCT01891994 (ClinicalTrials.gov) | June 28, 2013 | 28/6/2013 | Extended Dosing With Eltrombopag for Severe Aplastic Anemia | Extended Dosing With Eltrombopag in Refractory Severe Aplastic Anemia | Severe Aplastic Anemia (SAA) | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Active, not recruiting | 2 Years | 100 Years | All | 40 | Phase 2 | United States |
| 27 | NCT01703169 (ClinicalTrials.gov) | November 2012 | 27/9/2012 | Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia | Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia | Severe Aplastic Anemia;Very Severe Aplastic Anemia;Moderate Aplastic Anemia | Drug: Eltrombopag | University of Utah | Novartis | Completed | 18 Years | N/A | All | 13 | Phase 2 | United States |
| 28 | NCT01623167 (ClinicalTrials.gov) | July 2, 2012 | 14/6/2012 | Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia | Eltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Cohort 1: hATG, CsA, EPAG Day 14 to Month 6;Drug: Cohort 2: hATG, CsA, EPAG Day 14 to Month 3;Drug: Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6;Drug: Extension Cohort | National Heart, Lung, and Blood Institute (NHLBI) | Novartis | Recruiting | 2 Years | 95 Years | All | 207 | Phase 1/Phase 2 | United States |
| 29 | NCT01328587 (ClinicalTrials.gov) | April 1, 2011 | 1/4/2011 | Eltrombopag for Moderate Aplastic Anemia | A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia Patients | Moderate Aplastic Anemia;Unilineage Bone Marrow Failure Disorders | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Active, not recruiting | 2 Years | 100 Years | All | 34 | Phase 2 | United States |
| 30 | NCT00922883 (ClinicalTrials.gov) | May 29, 2009 | 16/6/2009 | A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients | A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Aplastic Anemia Patients With Immunosuppressive-Therapy Refractory Thrombocytopenia | Anemia, Aplastic;Anemia, Hypoplastic;Thrombocytopenia | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 12 Years | N/A | All | 43 | Phase 2 | United States |
63. 特発性血小板減少性紫斑病
臨床試験数 : 363 / 薬物数 : 212 - (DrugBank : 43) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 138
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04812483 (ClinicalTrials.gov) | May 2022 | 1/3/2021 | Immunomodulation With Eltrombopag in ITP | Immunomodulation in Young Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose Dexamethasone | Primary Immune Thrombocytopenia (ITP) | Drug: Eltrombopag (Revolade®);Drug: standard therapy (without eltrombopag): HD-DXM | University Children's Hospital Basel | Stiftung zur Förderung medizinischer und biologischer Forschung;Novartis Pharmaceuticals;University of Erlangen-Nürnberg, Department of Biology | Recruiting | 18 Years | 45 Years | All | 24 | Phase 2 | Switzerland |
| 2 | ChiCTR2000040991 | 2022-03-02 | 2020-12-16 | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | primary immune thrombocytopenia | experimental group:Cyclosporine A combined with eltrombopag; | The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Recruiting | 18 | 75 | Both | experimental group:28; | Phase 4 | China |
| 3 | NCT04890041 (ClinicalTrials.gov) | May 30, 2021 | 12/5/2021 | Avatrombopag in Primary Immune Thrombocytopenia (ITP) in Adults | Efficacy and Safety of Avatrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults With Poor Efficacy of Eltrombopag or rhTPO: a Single-center, Prospective, One-arm Study | Primary Immune Thrombocytopenic Purpura | Drug: Avatrombopag | Institute of Hematology & Blood Diseases Hospital | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | China |
| 4 | NCT04917679 (ClinicalTrials.gov) | September 1, 2020 | 1/12/2020 | Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP | Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial | Thrombocytopenia | Drug: Eltrombopag plus diacerein;Drug: Eltrombopag | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | China |
| 5 | NCT04518475 (ClinicalTrials.gov) | August 10, 2020 | 12/8/2020 | Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults | A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients | Primary Immune Thrombocytopenia (ITP) | Drug: eltrombopag combining rituximab;Drug: eltrombopag | Institute of Hematology & Blood Diseases Hospital | The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong University | Recruiting | 18 Years | 60 Years | All | 224 | Phase 4 | China |
| 6 | ChiCTR2000030603 | 2020-05-01 | 2020-03-08 | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Primary Immune Thrombocytopenia | The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine; | The Second Affiliated Hospital of Kunming Medical University | NULL | Pending | 18 | 75 | Both | The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65; | Phase 4 | China |
| 7 | NCT04214951 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2019 | A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | Corticosteroid-resistant or Relapsed ITP | Drug: Eltrombopag;Drug: Recombinant human thrombopoietin (rh-TPO) | Peking University People's Hospital | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | China | |
| 8 | NCT03771378 (ClinicalTrials.gov) | January 16, 2019 | 7/12/2018 | Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) | Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled Trial | Primary Immune Thrombocytopenia | Drug: rhTPO;Drug: eltrombopag | Wuhan Union Hospital, China | The First Affiliated Hospital of Nanchang University;The Third Xiangya Hospital of Central South University;The First People's Hospital of Yuhang District;Xiangyang Central Hospital | Recruiting | 18 Years | 75 Years | All | 96 | Phase 4 | China |
| 9 | NCT03412188 (ClinicalTrials.gov) | August 1, 2018 | 20/1/2018 | The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP. | Evaluation of the Effect of Eltrombopag on the Expression of Platelet Collagen Receptor Glycoprotein VI (GPVI) in Pediatric Patients With Chronic and Persistent Immune Thrombocytopenia. | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: conventional | Nayera Hazaa Elsherif | NULL | Completed | 1 Year | 18 Years | All | 36 | N/A | Egypt |
| 10 | NCT03830749 (ClinicalTrials.gov) | July 1, 2018 | 1/2/2019 | Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura | A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenia | Drug: Eltrombopag | Humanity & Health Medical Group Limited | NULL | Suspended | 18 Years | N/A | All | 60 | Phase 2 | Hong Kong |
| 11 | NCT02298075 (ClinicalTrials.gov) | April 2016 | 17/11/2014 | Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia | Response Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective Study | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostin | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Unknown status | 18 Years | N/A | All | 100 | Italy | |
| 12 | NCT02402998 (ClinicalTrials.gov) | February 24, 2016 | 22/3/2015 | Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia | Eltrombopag as Second Line Therapy in Adult Patients With Primary Immune Thrombocytopenia (ESTIT Study) in an Attempt to Achieve Long-term Remission: a Single Arm Multicenter Phase II Clinical and Biological Study | Primacy Immune Thrombocytopenia | Drug: Eltrombopag | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Completed | 18 Years | N/A | All | 55 | Phase 2 | Italy |
| 13 | EUCTR2015-001327-23-IT (EUCTR) | 26/06/2015 | 29/04/2015 | Study about the effect of a drug (Eltrombopag)which is administered in patients with thrombocytopenia primary Immune, a relative decrease of platelets in blood (small blood components that help the clotting process by sticking to the lining of blood vessels). | Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study | Primary Immune Thrombocytopenia MedDRA version: 18.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE | Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'Adulto | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | Italy | ||
| 14 | ChiCTR1900021211 | 2015-04-01 | 2019-02-01 | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | immune thrombocytopenia (ITP) | 1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses; | University Hospital, Macau | NULL | Recruiting | 18 | 100 | Both | 1:60; | China | |
| 15 | EUCTR2013-001371-20-NL (EUCTR) | 06/05/2014 | 19/03/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 16 | EUCTR2013-001371-20-PL (EUCTR) | 11/04/2014 | 24/02/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 17 | EUCTR2013-001371-20-GR (EUCTR) | 10/12/2013 | 11/11/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of | |||
| 18 | EUCTR2013-001371-20-BE (EUCTR) | 15/10/2013 | 10/09/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 17.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 17.0;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 19 | EUCTR2013-001371-20-ES (EUCTR) | 15/10/2013 | 08/08/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 20 | EUCTR2013-001371-20-IE (EUCTR) | 06/09/2013 | 11/07/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 14.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 21 | EUCTR2011-000831-10-DE (EUCTR) | 18/07/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 22 | EUCTR2011-000831-10-BE (EUCTR) | 16/07/2012 | 15/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 23 | EUCTR2011-000831-10-GB (EUCTR) | 02/07/2012 | 28/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 24 | EUCTR2011-000831-10-AT (EUCTR) | 05/06/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 25 | EUCTR2011-000831-10-ES (EUCTR) | 25/05/2012 | 29/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 26 | EUCTR2011-000831-10-NL (EUCTR) | 24/05/2012 | 24/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 27 | EUCTR2011-002184-17-DE (EUCTR) | 04/05/2012 | 13/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 28 | EUCTR2011-002184-17-PL (EUCTR) | 17/04/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 29 | NCT01433978 (ClinicalTrials.gov) | March 26, 2012 | 13/9/2011 | A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of care | Eisai Inc. | NULL | Terminated | 18 Years | 99 Years | All | 24 | Phase 3 | United States |
| 30 | EUCTR2011-002184-17-IT (EUCTR) | 07/03/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).PETIT2: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT2 | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;Argentina;Poland;Germany | |||
| 31 | EUCTR2011-002184-17-GB (EUCTR) | 02/03/2012 | 17/01/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: E | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 32 | NCT01520909 (ClinicalTrials.gov) | March 2012 | 21/12/2011 | Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. | A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 92 | Phase 3 | United States;Argentina;Czech Republic;Germany;Hong Kong;Israel;Italy;Poland;Russian Federation;Spain;Taiwan;Thailand;United Kingdom;Chile |
| 33 | EUCTR2011-002184-17-ES (EUCTR) | 23/02/2012 | 21/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | Pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | Glaxosmithkline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 34 | EUCTR2011-002184-17-CZ (EUCTR) | 08/02/2012 | 08/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 35 | EUCTR2006-002946-13-NL (EUCTR) | 19/04/2011 | 15/12/2010 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | France;Spain;Netherlands;United Kingdom | |||
| 36 | NCT01416311 (ClinicalTrials.gov) | December 21, 2010 | 9/6/2011 | Drug Use Investigation for REVOLADE (ITP) | Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura) | Purpura, Thrombocytopaenic, Idiopathic | Drug: Eltrombopag | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 5797 | NULL | |
| 37 | EUCTR2009-010421-39-FR (EUCTR) | 25/05/2010 | 09/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;Hungary;Czech Republic;Germany;Italy | ||
| 38 | EUCTR2009-010421-39-CZ (EUCTR) | 06/05/2010 | 03/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Hungary;Czech Republic;Germany;Italy | |||
| 39 | EUCTR2009-010421-39-HU (EUCTR) | 05/05/2010 | 10/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Czech Republic;Hungary;Germany;Italy | |||
| 40 | EUCTR2009-010421-39-DE (EUCTR) | 10/03/2010 | 04/02/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Hungary;Czech Republic;Germany;Italy | |||
| 41 | NCT00908037 (ClinicalTrials.gov) | September 30, 2009 | 21/5/2009 | Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 82 | Phase 2 | United States;Canada;France;Netherlands;Spain;United Kingdom |
| 42 | EUCTR2006-002946-13-GB (EUCTR) | 18/09/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Netherlands;United Kingdom | ||
| 43 | EUCTR2006-002946-13-FR (EUCTR) | 18/09/2009 | 05/08/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 44 | EUCTR2006-002946-13-ES (EUCTR) | 30/07/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | Chronic Idiopathic Thrombocytopenic PurpuraPúrpura Trombocitopénica Idiopática Crónica MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 45 | NCT00888901 (ClinicalTrials.gov) | May 2009 | 27/4/2009 | Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag | Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. | Idiopathic Thrombocytopenic Purpura | Drug: eltrombopag;Drug: corticosteroids (Aprednislon) | Ingrid Pabinger, MD | GlaxoSmithKline | Completed | 18 Years | 90 Years | Both | 30 | Phase 4 | Austria |
| 46 | NCT00902018 (ClinicalTrials.gov) | January 2009 | 8/5/2009 | Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP) | The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostim;Other: healthy controls | Weill Medical College of Cornell University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 47 | EUCTR2006-000471-14-IE (EUCTR) | 02/08/2008 | 05/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 48 | NCT00828750 (ClinicalTrials.gov) | May 2008 | 22/1/2009 | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)- | Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: Eltrombopag oral tablets | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 19 | Phase 3 | Japan |
| 49 | EUCTR2006-000471-14-FI (EUCTR) | 30/11/2007 | 08/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 50 | EUCTR2006-000471-14-IT (EUCTR) | 16/11/2007 | 13/09/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | Idiopathic thrombocytopenic purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag | GLAXOSMITHKLINE R&D LTD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 51 | EUCTR2006-000471-14-AT (EUCTR) | 11/11/2007 | 23/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 52 | EUCTR2006-000471-14-DE (EUCTR) | 26/10/2007 | 30/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 53 | EUCTR2006-000471-14-DK (EUCTR) | 01/10/2007 | 14/08/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 54 | EUCTR2006-000470-78-CZ (EUCTR) | 01/10/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 55 | EUCTR2006-000471-14-CZ (EUCTR) | 16/08/2007 | 24/07/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 56 | EUCTR2006-002943-10-ES (EUCTR) | 19/04/2007 | 21/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Spain;Germany;United Kingdom | ||
| 57 | EUCTR2006-002943-10-GB (EUCTR) | 13/04/2007 | 26/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 58 | EUCTR2006-000470-78-GR (EUCTR) | 27/03/2007 | 03/01/2007 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 59 | EUCTR2006-002943-10-DE (EUCTR) | 16/03/2007 | 28/03/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | United Kingdom;Germany;Spain | |||
| 60 | NCT00424177 (ClinicalTrials.gov) | March 2007 | 17/1/2007 | Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) | An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States |
| 61 | EUCTR2006-000471-14-GR (EUCTR) | 27/02/2007 | 04/09/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 62 | EUCTR2006-000470-78-DE (EUCTR) | 14/02/2007 | 05/12/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 63 | EUCTR2006-000471-14-SK (EUCTR) | 23/01/2007 | 30/11/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 64 | EUCTR2006-000470-78-SK (EUCTR) | 17/01/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 65 | EUCTR2006-000470-78-IT (EUCTR) | 17/01/2007 | 05/02/2007 | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | Idiopathic thrombocytopenic purpura ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR Product Name: Eltrombopag Product Code: SB-497115-GR | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 66 | EUCTR2006-000470-78-FR (EUCTR) | 22/12/2006 | 16/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 67 | EUCTR2006-000470-78-FI (EUCTR) | 12/12/2006 | 25/10/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 68 | EUCTR2006-000470-78-DK (EUCTR) | 29/11/2006 | 10/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 69 | EUCTR2006-000470-78-GB (EUCTR) | 22/11/2006 | 08/05/2008 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom | ||
| 70 | EUCTR2006-000470-78-AT (EUCTR) | 22/11/2006 | 20/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 71 | EUCTR2006-000470-78-ES (EUCTR) | 22/11/2006 | 13/04/2012 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Russian Federation;Italy;Vietnam;India;France;Denmark;Peru;Netherlands;Tunisia;China;Finland;Austria;United Kingdom;Czech Republic;Canada;Brazil;Poland;Germany;New Zealand | ||
| 72 | NCT00370331 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag | A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 197 | Phase 3 | United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia |
| 73 | EUCTR2006-000470-78-NL (EUCTR) | 30/10/2006 | 01/09/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 74 | EUCTR2006-000471-14-GB (EUCTR) | 23/10/2006 | 03/06/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune Thrombocytopenic Purpura (ITP) MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 75 | EUCTR2006-000471-14-NL (EUCTR) | 23/08/2006 | 21/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 76 | EUCTR2006-000471-14-SE (EUCTR) | 14/08/2006 | 29/05/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 77 | EUCTR2006-000471-14-FR (EUCTR) | 16/06/2006 | 24/11/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 78 | EUCTR2006-000471-14-SI (EUCTR) | 13/06/2006 | 23/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece | |||
| 79 | NCT00351468 (ClinicalTrials.gov) | June 2006 | 10/7/2006 | EXTEND (Eltrombopag Extended Dosing Study) | EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag olamine (SB-497115-GR) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 302 | Phase 3 | United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway |
| 80 | EUCTR2006-002946-13-Outside-EU/EEA (EUCTR) | 24/02/2012 | A study of a new medication, eltrombopag, for the treatment of childhood chronic immune thrombocytopenic purpura (ITP), a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA | GlaxoSmithKline Research & Development Limited | NULL | NA | Female: yes Male: yes | 70 | Canada;United States |
65. 原発性免疫不全症候群
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04371939 (ClinicalTrials.gov) | November 5, 2019 | 29/4/2020 | Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome | Randomized, Two-arm Single-center Phase II Clinical Trial Comparing the Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome | Wiskott-Aldrich Syndrome | Drug: Romiplostim;Drug: Eltrombopag | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | N/A | 18 Years | All | 30 | Phase 2 | Russian Federation |
| 2 | NCT00909363 (ClinicalTrials.gov) | June 2009 | 27/5/2009 | Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients | Effects Of Eltrombopag On Thrombocytopenia, Platelet Function and Bleeding In Patients With Wiskott-Aldrich Syndrome/X-Linked Thrombocytopenia. | Wiskott-Aldrich Syndrome;Thrombocytopenia;Bleeding | Drug: Promacta;Diagnostic Test: blood drawing in patients with WAS;Diagnostic Test: blood drawing in healthy controls | Weill Medical College of Cornell University | Novartis Pharmaceuticals | Terminated | 3 Months | 80 Years | Male | 24 | Phase 2 | United States |
284. ダイアモンド・ブラックファン貧血
臨床試験数 : 37 / 薬物数 : 110 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 124
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04269889 (ClinicalTrials.gov) | December 1, 2020 | 13/2/2020 | Treatment of Refractory Diamond-Blackfan Anemia With Eltrombopag | Treatment of Refractory Diamond-Blackfan Anemia With Eltrombopag | Anemia, Diamond-Blackfan | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 2 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
285. ファンコニ貧血
臨床試験数 : 59 / 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 155
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03206086 (ClinicalTrials.gov) | November 2, 2018 | 30/6/2017 | Eltrombopag for People With Fanconi Anemia | Eltrombopag for Patients With Fanconi Anemia | Fanconi Anemia | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 2 Years | N/A | All | 35 | Phase 2 | United States |