Afamelanotide (DrugBank: Afamelanotide)
2 diseasesID | Disease name (Link within this page) | Number of trials |
---|---|---|
161 | Familial benign chronic pemphigus | 1 |
254 | Porphyria | 10 |
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 |
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1 | EUCTR2013-004562-33-IT (EUCTR) | 17/12/2013 | 18/11/2013 | PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS | PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS | SYMPTOMATIC HHD PATIENTS MedDRA version: 16.1;Level: LLT;Classification code 10019029;Term: Hailey-Hailey disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE | ISTITUTI FISIOTERAPICI OSPITALIERI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Italy |
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 |
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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 | NCT04578496 (ClinicalTrials.gov) | July 11, 2011 | 5/10/2020 | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 3 | NULL |
3 | 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 |
4 | 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 | ||
5 | 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 |
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 |
6 | 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 | ||
7 | 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 | ||
8 | 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 | ||
9 | 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 |
10 | 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 |