Afamelanotide Implant ( DrugBank: Afamelanotide )
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 | 7 |
254. ポルフィリン症
臨床試験数 : 72 / 薬物数 : 53 - (DrugBank : 16) / 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 | NCT01605136 (ClinicalTrials.gov) | May 2012 | 22/5/2012 | Phase III Confirmatory Study in Erythropoietic Protoporphyria | A Phase III, Multicentre, Double-Blind, Randomized, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | N/A | All | 93 | Phase 3 | United States |
| 2 | NCT01097044 (ClinicalTrials.gov) | April 2010 | 30/3/2010 | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | A Phase II, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States |
| 3 | 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 | ||
| 4 | NCT00979745 (ClinicalTrials.gov) | September 2009 | 17/9/2009 | Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) | 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) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 70 Years | Both | 70 | Phase 3 | Finland;France;Germany;Ireland;Netherlands;United Kingdom |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 |