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Afamelanotide    (DrugBank: Afamelanotide)

2 diseases
告示番号疾患名（ページ内リンク）臨床試験数
161家族性良性慢性天疱瘡1
254ポルフィリン症10

161. 家族性良性慢性天疱瘡　［臨床試験数：4，薬物数：8（DrugBank：3），標的遺伝子数：1，標的パスウェイ数：22］
Searched query = "Familial benign chronic pemphigus", "Benign familial pemphigus", "Hailey-Hailey disease"
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.
1 / 4 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2013-004562-33-IT
(EUCTR)		17/12/201318/11/2013PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTSPHASE 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 OSPITALIERINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		10Phase 2Italy

254. ポルフィリン症　［臨床試験数：59，薬物数：52（DrugBank：17），標的遺伝子数：17，標的パスウェイ数：33］
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

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