63. 特発性血小板減少性紫斑病
［臨床試験数：311，薬物数：185（DrugBank：39），標的遺伝子数：43，標的パスウェイ数：132］
Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
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 | EUCTR2019-000883-40-GB (EUCTR) | 29/10/2020 | 11/09/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 2 | EUCTR2019-000883-40-PL (EUCTR) | 09/10/2020 | 25/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 3 | EUCTR2019-000883-40-CZ (EUCTR) | 05/10/2020 | 12/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 4 | EUCTR2019-000883-40-HU (EUCTR) | 29/09/2020 | 11/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 5 | EUCTR2019-003451-11-DE (EUCTR) | 17/08/2020 | 14/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 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 | EUCTR2019-003451-11-AT (EUCTR) | 13/07/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 7 | EUCTR2019-000884-26-AT (EUCTR) | 06/07/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan | ||
| 8 | EUCTR2019-003451-11-NL (EUCTR) | 22/05/2020 | 03/03/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan | ||
| 9 | EUCTR2019-000884-26-FR (EUCTR) | 11/05/2020 | 26/05/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 10 | EUCTR2019-003451-11-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 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 |
| 11 | EUCTR2019-000884-26-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 12 | EUCTR2019-000884-26-CZ (EUCTR) | 23/04/2020 | 25/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan | ||
| 13 | EUCTR2019-003451-11-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan | ||
| 14 | EUCTR2019-000884-26-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 15 | EUCTR2019-000884-26-GB (EUCTR) | 20/04/2020 | 16/03/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan | ||
| 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 |
| 16 | EUCTR2019-000884-26-HU (EUCTR) | 13/04/2020 | 11/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Georgia;Bulgaria;Germany;Japan;United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania | ||
| 17 | EUCTR2019-003451-11-PL (EUCTR) | 25/03/2020 | 11/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan | ||
| 18 | EUCTR2019-000884-26-PL (EUCTR) | 20/03/2020 | 03/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 19 | EUCTR2015-003984-12-BG (EUCTR) | 15/08/2017 | 02/06/2017 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;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] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 20 | EUCTR2015-003984-12-LT (EUCTR) | 14/07/2017 | 02/05/2017 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 19.1;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
| 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 |
| 21 | EUCTR2015-003984-12-PL (EUCTR) | 09/06/2016 | 06/04/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Poland;Belgium;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
| 22 | EUCTR2015-003984-12-IT (EUCTR) | 11/04/2016 | 05/11/2020 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA - - | Primary immune thrombocytopenia (ITP) MedDRA version: 20.0;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] | Product Name: UCB7665 Product Code: [UCB7665 ] INN or Proposed INN: UCB7665 | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Czechia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 23 | EUCTR2015-003984-12-CZ (EUCTR) | 16/03/2016 | 22/12/2015 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
| 24 | NCT02718716 (ClinicalTrials.gov) | March 2016 | 11/3/2016 | Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia | A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia | Thrombocytopenia | Drug: UCB7665 | UCB Biopharma S.P.R.L. | Parexel | Completed | 18 Years | N/A | All | 66 | Phase 2 | Australia;Bulgaria;Czechia;Georgia;Germany;Italy;Moldova, Republic of;Poland;Romania;Spain;United Kingdom;Belgium;Czech Republic;Lithuania |
| 25 | EUCTR2015-003984-12-ES (EUCTR) | 29/02/2016 | 13/01/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | Primary immune thrombocytopenia (ITP) MedDRA version: 18.1;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of | |||
| 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 |
| 26 | EUCTR2015-003984-12-BE (EUCTR) | 22/02/2016 | 15/01/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 19.1;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | |||
| 27 | EUCTR2015-003984-12-DE (EUCTR) | 05/02/2016 | 23/11/2015 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;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] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of |