A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study
- Conditions
- Erythropoietic Protoporphyria (EPP)MedDRA version: 9.1Level: LLTClassification code 10036181Term: Porphyria
- Registration Number
- EUCTR2007-000636-13-IT
- Lead Sponsor
- CLINUVEL PHARMACUETICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
-Male or female subjects with a positive diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Allergy to CUV1647 or the polymer contained in the implant or to lignocaine or other local anaesthetic to be used during the administration of the study medication -Current Bowen?s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions. -Any other photodermatosis such as PLE, DLE or solar urticaria. -Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method