60. 再生不良性貧血
［臨床試験数：218，薬物数：362（DrugBank：81），標的遺伝子数：39，標的パスウェイ数：155］
Searched query = "Aplastic anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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 | |||
| 7 | 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 |