Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP)

Phase 1

• Conditions: xeroderma pigmentosum; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2019-000597-34-DE
• Lead Sponsor: CLINUVEL EUROPE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-11
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

- Male or female patient with a molecular-genetically confirmed
diagnosis of XPC.
- 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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Known allergy to afamelanotide or the polymer contained in the
implant or to lignocaine/ lidocaine or other local anaesthetic to be used during the administration of the implant, if applicable.
- Presence of severe hepatic disease.
- 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 lifestyle excluding pregnancy, for up to three months after the last implant administration.
- Sexually active man with a partner of child-bearing potential (premenopausal, 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