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
| 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 | EUCTR2021-003149-39-PT (EUCTR) | 25/05/2022 | 07/02/2022 | Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | United States;Portugal;Spain;Belgium;Denmark;Australia;Japan;Italy | ||
| 2 | NCT05116046 (ClinicalTrials.gov) | December 24, 2021 | 18/10/2021 | Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in 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 | Biological: Recifercept | Pfizer | NULL | Active, not recruiting | 15 Months | 12 Years | All | 30 | Phase 2 | United States;Australia;Belgium;Denmark;Italy;Portugal;Spain |
| 3 | EUCTR2021-003149-39-ES (EUCTR) | 14/12/2021 | 17/09/2021 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Belgium;Spain;Denmark;Australia;Italy;Japan | ||
| 4 | EUCTR2020-001189-13-PT (EUCTR) | 26/02/2021 | 29/09/2020 | Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasia | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | United States;Portugal;Spain;Belgium;Denmark;Australia;United Kingdom;Italy;Japan | ||
| 5 | EUCTR2020-001189-13-IT (EUCTR) | 05/02/2021 | 15/06/2021 | Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasia | A 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 INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Spain;Belgium;Denmark;Australia;United Kingdom;Japan;Italy | ||
| 6 | EUCTR2020-001189-13-DK (EUCTR) | 22/12/2020 | 07/10/2020 | Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasia | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Spain;Belgium;Australia;Denmark;Italy;Japan | ||
| 7 | NCT04638153 (ClinicalTrials.gov) | December 2, 2020 | 15/9/2020 | A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia | A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA | Achondroplasia | Biological: Recifercept | Pfizer | NULL | Active, not recruiting | 3 Months | 10 Years | All | 61 | Phase 2 | United States;Australia;Belgium;Denmark;Italy;Japan;Portugal;Spain |
| 8 | EUCTR2021-003149-39-DK (EUCTR) | 10/03/2022 | Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in 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: 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. | NULL | NA | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Belgium;Spain;Australia;Denmark;Italy;Japan | |||
| 9 | EUCTR2021-003149-39-BE (EUCTR) | 07/03/2022 | Phase 2 study of long-term safety, tolerability, PK and efficacy of recifercept in 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. | NULL | NA | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Spain;Belgium;Denmark;Australia;Italy;Japan | |||
| 10 | EUCTR2020-001189-13-BE (EUCTR) | 10/02/2021 | Phase 2 study of safety, tolerability, PK and efficacy of recifercept in achondroplasia | A 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 10017 | NULL | NA | Female: yes Male: yes | 63 | Phase 2 | Portugal;United States;Spain;Belgium;Denmark;Australia;Italy;Japan |