A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study

• Conditions: Erythropoietic Protoporphyria (EPP); MedDRA version: 13.1Level: LLTClassification code 10015289Term: Erythropoietic protoporphyriaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2009-011018-51-GB
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-27
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

- Male or female subjects with a positive diagnosis of EPP who successfully completed the CUV029 study
- Aged 18-75 years (inclusive)
- Provide written Informed Patient Consent prior to the performance of any study-specific procedure.
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

Exclusion Criteria

- Any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant.
- Any allergy to lignocaine or other local anaesthetic to be used during the administration of the study medication
- EPP patients with significant hepatic involvement
- Personal history of melanoma or dysplastic nevus syndrome.
- Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
- Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.
- Acute history of drug or alcohol abuse (in the last 12 months).
- Female who is pregnant 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).
- Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months thereafter.
- Participation in a clinical trial for another investigational agent within 30 days prior to the screening visit.
- Prior and concomitant therapy with medications which may interfere with the objectives of the study.

Study & Design

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