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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000883-40-GB29/10/202011/09/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United 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
2EUCTR2019-000883-40-PL09/10/202025/08/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United 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
3EUCTR2019-000883-40-CZ05/10/202012/08/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United 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
4EUCTR2019-000883-40-HU29/09/202011/08/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United 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
5EUCTR2019-003451-11-DE17/08/202014/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003451-11-AT13/07/202028/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
7EUCTR2019-000884-26-AT06/07/202028/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
8EUCTR2019-003451-11-NL22/05/202003/03/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
9EUCTR2019-000884-26-FR11/05/202026/05/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
10EUCTR2019-003451-11-BG30/04/202004/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000884-26-BG30/04/202004/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
12EUCTR2019-000884-26-CZ23/04/202025/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
13EUCTR2019-003451-11-ES22/04/202028/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
14EUCTR2019-000884-26-ES22/04/202028/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
15EUCTR2019-000884-26-GB20/04/202016/03/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-000884-26-HU13/04/202011/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Georgia;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
17EUCTR2019-003451-11-PL25/03/202011/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
18EUCTR2019-000884-26-PL20/03/202003/02/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United 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
19EUCTR2015-003984-12-BG15/08/201702/06/2017A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
20EUCTR2015-003984-12-LT14/07/201702/05/2017A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-003984-12-PL09/06/201606/04/2016A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Poland;Belgium;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
22EUCTR2015-003984-12-IT11/04/201605/11/2020A 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: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem 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 SRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Czechia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
23EUCTR2015-003984-12-CZ16/03/201622/12/2015A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
24NCT02718716March 201611/3/2016Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaA Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaThrombocytopeniaDrug: UCB7665UCB Biopharma S.P.R.L.ParexelCompleted18 YearsN/AAll66Phase 2Australia;Bulgaria;Czechia;Georgia;Germany;Italy;Moldova, Republic of;Poland;Romania;Spain;United Kingdom;Belgium;Czech Republic;Lithuania
25EUCTR2015-003984-12-ES29/02/201613/01/2016A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
26EUCTR2015-003984-12-BE22/02/201615/01/2016A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
27EUCTR2015-003984-12-DE05/02/201623/11/2015A 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 SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of