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


臨床試験数 : 46 薬物数 : 29 - (DrugBank : 6) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 30

  
8 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-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
2NCT05116046
(ClinicalTrials.gov)
December 7, 202118/10/2021Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics 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 ACHONDROPLASIAAchondroplasiaBiological: ReciferceptPfizerNULLNot yet recruiting15 Months12 YearsAll63Phase 2NULL
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-IT
(EUCTR)
05/02/202115/06/2021Phase 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
MedDRA version: 20.0;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Recifercept
Product Code: [PF-07256472]
INN or Proposed INN: Recifercept
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Portugal;United States;Spain;Belgium;Denmark;Australia;United Kingdom;Japan;Italy
5EUCTR2020-001189-13-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
6NCT04638153
(ClinicalTrials.gov)
December 2, 202015/9/2020A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With AchondroplasiaA PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIAAchondroplasiaBiological: ReciferceptPfizerNULLRecruiting3 Months10 YearsAll63Phase 2United States;Australia;Belgium;Denmark;Italy;Portugal;Spain
7EUCTR2020-001189-13-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
8EUCTR2021-003149-39-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 2United States;Portugal;Spain;Belgium;Australia;Denmark;Japan;Italy