Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V

Phase 1

• Conditions: Patients with Xeroderma Pigmentosum C and V; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2021-001419-10-ES
• Lead Sponsor: CLINUVEL EUROPE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

-Male or female patient with a molecular-genetically confirmed diagnosis of XPC or XPV.
-Aged 18-75 years.
-Providing written Informed Consent prior to the performance of any study-specific procedure.
-Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

-Known allergy to afamelanotide or the polymer contained in the implant;
-Presence of severe hepatic disease or hepatic impairment;
-Renal impairment;
-Any other medical condition which may interfere with the study protocol;
-Existing melanoma;
-Female who is pregnant (confirmed by positive urine ß-HCG pregnancy test) or lactating;
-Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a life-style excluding pregnancy, for up to three months after the last implant administration;
-Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using adequate contraceptive measures, as described above;
-Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit;
-Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit;
-Not suitable for trial participation in the opinion of the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified