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 : 72 薬物数 : 53 - (DrugBank : 16) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-011018-51-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
2EUCTR2009-011018-51-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
3EUCTR2009-011018-51-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
4EUCTR2009-011018-51-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
5EUCTR2007-000636-13-NL
(EUCTR)
18/09/200807/01/2009A 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: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: CUV1647
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3Germany;United Kingdom;Netherlands;France;Italy;Sweden
6EUCTR2007-000636-13-FR
(EUCTR)
08/07/200809/05/2008A 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: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: CUV1647
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3France;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2007-000636-13-GB
(EUCTR)
17/06/200829/02/2008A 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: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: CUV1647
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot 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): noFrance;Netherlands;Germany;Italy;United Kingdom;Sweden
8EUCTR2007-000636-13-SE
(EUCTR)
27/05/200803/04/2008A 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: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: CUV1647
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3Germany;United Kingdom;Netherlands;France;Italy;Sweden
9EUCTR2007-000636-13-IT
(EUCTR)
27/07/200715/04/2008A 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: 9.1;Level: LLT;Classification code 10036181;Term: Porphyria
Product Name: CUV1647
INN or Proposed INN: Nle4-D-Phe7-alpha-MSH
CLINUVEL PHARMACUETICALS LTDNULLNot RecruitingFemale: yes
Male: yes
80Phase 3Germany;United Kingdom;Netherlands;France;Italy;Sweden
10NCT04053270
(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
11EUCTR2007-000636-13-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