EUCTR2021-001419-10-ESActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CLINUVEL EUROPE LIMITED
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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