159. 色素性乾皮症 Xeroderma pigmentosum Clinical trials / Disease details
臨床試験数 : 11 / 薬物数 : 17 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 15
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05370235 (ClinicalTrials.gov) | March 28, 2022 | 21/4/2022 | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V | 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 C and V (XPC and XPV) | Xeroderma Pigmentosum | Drug: Afamelanotide | Clinuvel Europe Limited | NULL | Recruiting | 18 Years | 75 Years | All | 6 | Phase 2 | Belgium;Spain |
| 2 | EUCTR2021-001419-10-ES (EUCTR) | 31/01/2022 | 17/11/2021 | Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | 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 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 LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Belgium;Spain | ||
| 3 | NCT05159752 (ClinicalTrials.gov) | October 19, 2021 | 9/11/2021 | A 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 Pigmentosum | Drug: Afamelanotide | Clinuvel Europe Limited | NULL | Recruiting | 18 Years | 75 Years | All | 6 | Phase 2 | Germany |
| 4 | EUCTR2021-003642-20-DE (EUCTR) | 27/09/2021 | 09/07/2021 | Study 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 LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 5 | EUCTR2019-000597-34-DE (EUCTR) | 01/06/2021 | 11/01/2021 | Study 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 LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 6 | NCT04500548 (ClinicalTrials.gov) | January 28, 2021 | 4/8/2020 | Testing 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 Study | 3CI 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 Cancers | Constitutional 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 Pigmentosum | Procedure: Biospecimen Collection;Biological: Ipilimumab;Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Withdrawn | 12 Months | 25 Years | All | 0 | Phase 1 | United States;Canada |
| 7 | EUCTR2010-022968-13-ES (EUCTR) | 22/03/2011 | 25/01/2011 | 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). | 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 Unipersonal | NULL | Not Recruiting | Female: yes Male: no | 100 | Phase 2 | Belgium;Spain | ||
| 8 | EUCTR2010-022968-13-BE (EUCTR) | 16/03/2011 | 04/01/2011 | Study 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 Unipersonal | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain;Belgium | ||
| 9 | NCT00002811 (ClinicalTrials.gov) | July 1996 | 1/11/1999 | T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum | A 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 KERATOSES | Precancerous Condition | Drug: liposomal T4N5 lotion | Applied Genetics | NULL | Active, not recruiting | 2 Years | 60 Years | Both | 30 | Phase 3 | United States;Germany;United Kingdom |
| 10 | NCT00025012 (ClinicalTrials.gov) | June 1991 | 11/10/2001 | Isotretinoin in Preventing Skin Cancer | Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome | Melanoma (Skin);Non-melanomatous Skin Cancer | Drug: isotretinoin | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | 2 Years | N/A | Both | N/A | United States | |
| 11 | EUCTR2021-001419-10-BE (EUCTR) | 16/11/2021 | Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | 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 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 LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Spain;Belgium |