CUV1647 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 254 | ポルフィリン症 | 11 |
254. ポルフィリン症
臨床試験数 : 70 / 薬物数 : 54 - (DrugBank : 19) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
| 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 | EUCTR2009-011018-51-IE (EUCTR) | 09/03/2010 | 20/01/2010 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP). MedDRA version: 12.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 INN or Proposed INN: Afamelanotide | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 2 | EUCTR2009-011018-51-FI (EUCTR) | 18/08/2009 | 20/04/2009 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 3 | EUCTR2009-011018-51-NL (EUCTR) | 06/08/2009 | 03/04/2009 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 4 | EUCTR2009-011018-51-GB (EUCTR) | 15/06/2009 | 27/04/2009 | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 13.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Afamelanotide Product Code: CUV1647 INN or Proposed INN: afamelanotide Other descriptive name: Trade Name: SCENESSE | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 5 | EUCTR2007-000636-13-NL (EUCTR) | 18/09/2008 | 07/01/2009 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: CUV1647 Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | Germany;United Kingdom;Netherlands;France;Italy;Sweden | ||
| 6 | EUCTR2007-000636-13-FR (EUCTR) | 08/07/2008 | 09/05/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: CUV1647 Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | France;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2007-000636-13-GB (EUCTR) | 17/06/2008 | 29/02/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: CUV1647 Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2007-000636-13-SE (EUCTR) | 27/05/2008 | 03/04/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: CUV1647 Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | Germany;United Kingdom;Netherlands;France;Italy;Sweden | ||
| 9 | EUCTR2007-000636-13-IT (EUCTR) | 27/07/2007 | 15/04/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10036181;Term: Porphyria | Product Name: CUV1647 INN or Proposed INN: Nle4-D-Phe7-alpha-MSH | CLINUVEL PHARMACUETICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | Germany;United Kingdom;Netherlands;France;Italy;Sweden | ||
| 10 | NCT04053270 (ClinicalTrials.gov) | May 2007 | 8/8/2019 | Multicentre Phase III Erythropoietic Protoporphyria Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 70 Years | All | 100 | Phase 3 | NULL |
| 11 | EUCTR2007-000636-13-DE (EUCTR) | 12/11/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 12.0;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: Afamelanotide Implant Product Code: CUV1647 INN or Proposed INN: afamelanotide Other descriptive name: [Nle4,D-Phe7]-a-melanocyte stimulating hormone or NDP-a-MSH | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United Kingdom;Germany;Netherlands;France;Italy;Sweden |