276. 軟骨無形成症 Achondroplasia Clinical trials / Disease details


臨床試験数 : 51 薬物数 : 34 - (DrugBank : 6) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 26

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003149-39-PT
(EUCTR)
25/05/202207/02/2022Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2United States;Portugal;Spain;Belgium;Denmark;Australia;Japan;Italy
2EUCTR2021-003149-39-ES
(EUCTR)
14/12/202117/09/2021A PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA A PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Portugal;United States;Belgium;Spain;Denmark;Australia;Italy;Japan
3EUCTR2020-001189-13-PT
(EUCTR)
26/02/202129/09/2020Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2United States;Portugal;Spain;Belgium;Denmark;Australia;United Kingdom;Italy;Japan
4EUCTR2020-001189-13-DK
(EUCTR)
22/12/202007/10/2020Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Portugal;United States;Spain;Belgium;Australia;Denmark;Italy;Japan
5EUCTR2021-003149-39-DK
(EUCTR)
10/03/2022Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 25.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc.NULLNAFemale: yes
Male: yes
63Phase 2Portugal;United States;Belgium;Spain;Australia;Denmark;Italy;Japan
6EUCTR2020-001189-13-BE
(EUCTR)
10/02/2021Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNAFemale: yes
Male: yes
63Phase 2Portugal;United States;Spain;Belgium;Denmark;Australia;Italy;Japan
7EUCTR2021-003149-39-BE
(EUCTR)
07/03/2022Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in achondroplasiaA PHASE 2 OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA Achondroplasia
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept (proposed INN)
Product Code: PF-07256472
INN or Proposed INN: Recifercept (proposed INN)
Other descriptive name: TA-46
Pfizer Inc.NULLNAFemale: yes
Male: yes
63Phase 2Portugal;United States;Spain;Belgium;Denmark;Australia;Italy;Japan