159. 色素性乾皮症 Xeroderma pigmentosum Clinical trials / Disease details


臨床試験数 : 10 薬物数 : 18 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 15

  
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2021-001419-10-ES
(EUCTR)
31/01/202217/11/2021Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and VA Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV) - Phase IIa XPC and XPV Study Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: SCENESSE
Product Name: Afamelanotide (16 mg implant)
CLINUVEL EUROPE LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Belgium;Spain
2NCT05159752
(ClinicalTrials.gov)
October 19, 20219/11/2021A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)Xeroderma PigmentosumDrug: AfamelanotideClinuvel Europe LimitedNULLRecruiting18 Years75 YearsAll6Phase 2Germany
3EUCTR2021-003642-20-DE
(EUCTR)
27/09/202109/07/2021Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP)A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: SCENESSE
Product Name: SCENESSE
INN or Proposed INN: Afamelanotide
CLINUVEL EUROPE LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Germany
4EUCTR2019-000597-34-DE
(EUCTR)
01/06/202111/01/2021Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP)A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: SCENESSE
Product Name: SCENESSE
INN or Proposed INN: AFAMELANOTIDE
CLINUVEL EUROPE LIMITEDNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Germany
5NCT04500548
(ClinicalTrials.gov)
January 28, 20214/8/2020Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study3CI Study: Childhood Cancer Combination Immunotherapy. Phase Ib and Expansion Study of Nivolumab Combination Immunotherapy in Children, Adolescent and Young Adult (CAYA) Patients With Relapsed/Refractory Hypermutant CancersConstitutional Mismatch Repair Deficiency Syndrome;Hematopoietic and Lymphoid Cell Neoplasm;Lynch Syndrome;Recurrent Lymphoma;Recurrent Malignant Solid Neoplasm;Recurrent Neuroblastoma;Recurrent Primary Central Nervous System Neoplasm;Refractory Lymphoma;Refractory Malignant Solid Neoplasm;Refractory Neuroblastoma;Refractory Primary Central Nervous System Neoplasm;Xeroderma PigmentosumProcedure: Biospecimen Collection;Biological: Ipilimumab;Biological: NivolumabNational Cancer Institute (NCI)NULLRecruiting12 Months25 YearsAll26Phase 1United States;Canada
6EUCTR2010-022968-13-ES
(EUCTR)
22/03/201125/01/2011Estudio clínico de fase II, multicéntrico, abierto de trabectedina (Yondelis®) en pacientes con cáncer de mama avanzado, HER2 negativo, positivo para receptores hormonales, con sobreexpresión o subexpresión del gen xeroderma pigmentosum de clase G (XPG).Estudio clínico de fase II, multicéntrico, abierto de trabectedina (Yondelis®) en pacientes con cáncer de mama avanzado, HER2 negativo, positivo para receptores hormonales, con sobreexpresión o subexpresión del gen xeroderma pigmentosum de clase G (XPG). Cáncer de mama avanzado.
MedDRA version: 13;Level: LLT;Classification code 10006204;Term: Carcinoma de mama
Trade Name: YONDELIS 0,25 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: TRABECTEDINA
Other descriptive name: TRABECTEDINA
Trade Name: YONDELIS 1 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: TRABECTEDINA
Other descriptive name: TRABECTEDINA
PharmaMar S.A. Sociedad UnipersonalNULLNot RecruitingFemale: yes
Male: no
100Phase 2Belgium;Spain
7EUCTR2010-022968-13-BE
(EUCTR)
16/03/201104/01/2011Study of the medicinal product Trabectedin in Patients with AdvancedBreast Carcinoma.Multicenter, Open-Label, Phase II Study of Trabectedin (Yondelis®) in Patients with Hormonal Receptors Positive, HER2 Negative, Advanced Breast Carcinoma, Overexpressing or Underexpressing Xeroderma Pigmentosum G Gene (XPG) Advanced Breast Carcinoma
MedDRA version: 14.0;Level: LLT;Classification code 10006204;Term: Breast carcinoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Yondelis 0.25 mg powder for concentrate for solution for infusion.
INN or Proposed INN: trabectedine
Trade Name: Yondelis 1 mg powder for concentrate for solution for infusion.
INN or Proposed INN: trabectedine
Pharma Mar, S.A. Sociedad UnipersonalNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Spain;Belgium
8NCT00002811
(ClinicalTrials.gov)
July 19961/11/1999T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma PigmentosumA RANDOMIZED, DOUBLE BLIND, MULTI-CENTER CLINICAL STUDY TO TEST THE SAFETY AND EFFICACY OF T4N5 LIPOSOME LOTION ON PATIENTS WITH XERODERMA PIGMENTOSUM IN THE PROTECTION AGAINST ACTINIC KERATOSESPrecancerous ConditionDrug: liposomal T4N5 lotionApplied GeneticsNULLActive, not recruiting2 Years60 YearsBoth30Phase 3United States;Germany;United Kingdom
9NCT00025012
(ClinicalTrials.gov)
June 199111/10/2001Isotretinoin in Preventing Skin CancerUse Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma SyndromeMelanoma (Skin);Non-melanomatous Skin CancerDrug: isotretinoinNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted2 YearsN/ABothN/AUnited States
10EUCTR2021-001419-10-BE
(EUCTR)
16/11/2021Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and VA Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV) - Phase IIa XPC and XPV Study Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: SCENESSE
Product Name: Afamelanotide (16 mg implant)
CLINUVEL EUROPE LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Spain;Belgium