Status:
UNKNOWN
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
Lead Sponsor:
Clinuvel Europe Limited
Conditions:
Xeroderma Pigmentosum
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the...
Eligibility Criteria
Inclusion
- Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
- Aged 18-75 years.
Exclusion
- 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 or lactating;
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
- Use of any other prior and concomitant therapy which may interfere with the objective of the study;
- Participation in a clinical trial for an investigational agent.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05370235
Start Date
March 28 2022
End Date
December 1 2024
Last Update
September 21 2023
Active Locations (2)
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1
CLINUVEL Investigational site
Clinuvel Investigational Site, Belgium
2
CLINUVEL Investigational site
Clinuvel Investigational Site, Spain