Afamelanotide    (DrugBank: Afamelanotide)

1 disease
IDDisease name (Link within this page)Number of trials
254Porphyria10

254. Porphyria    [ 59 clinical trials,   52 drugs,   (DrugBank: 17 drugs),   17 drug target genes,   33 drug target pathways]
Searched query = "Porphyria", "CEP", "Erythropoietic protoporphyria", "EPP", "X-linked dominant protoporphyria", "XLDP", "PCT", "HEP", "AIP", "ADP", "VP", "Hereditary coproporphyria", "HCP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
10 / 59 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01605136
(ClinicalTrials.gov)
May 201222/5/2012Phase III Confirmatory Study in Erythropoietic ProtoporphyriaA 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 ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 YearsN/AAll93Phase 3United States
2NCT04578496
(ClinicalTrials.gov)
July 11, 20115/10/2020A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: AfamelanotideClinuvel Pharmaceuticals LimitedNULLCompleted18 Years75 YearsAll16Phase 3NULL
3NCT01097044
(ClinicalTrials.gov)
April 201030/3/2010Phase 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 ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 YearsN/AAll77Phase 2United States
4EUCTR2009-011018-51-IE
(EUCTR)
09/03/201020/01/2010A 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 2A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
5NCT00979745
(ClinicalTrials.gov)
September 200917/9/2009Phase 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 ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 Years70 YearsBoth70Phase 3Finland;France;Germany;Ireland;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-011018-51-FI
(EUCTR)
18/08/200920/04/2009A 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 2A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
7EUCTR2009-011018-51-NL
(EUCTR)
06/08/200903/04/2009A 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 2A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
8EUCTR2009-011018-51-GB
(EUCTR)
15/06/200927/04/2009A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension StudyA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
15Phase 3Finland;United Kingdom;Netherlands;Ireland
9NCT04053270
(ClinicalTrials.gov)
May 20078/8/2019Multicentre Phase III Erythropoietic Protoporphyria StudyA 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 ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 Years70 YearsAll100Phase 3NULL
10EUCTR2007-000636-13-DE
(EUCTR)
12/11/2008A 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 StudyA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United Kingdom;Germany;Netherlands;France;Italy;Sweden