Phase II Study of CUV1647 in Erythropoietic Protoporphyria (EPP)
A Multicentre, Phase II, Open Label Study to Evaluate the Safety of CUV1647 and to Evaluate the Effect of Subcutaneous Implants of CUV1647 on the Time to Artificially Provoked Symptoms in Patients with Erythropoietic Protoporphyria (EPP)
Clinuvel Pharmaceuticals
10 participants
Sep 1, 2006
Interventional
Conditions
Summary
The study is intended to determine if CUV1647 can increase the tolerance of patients with EPP to sunlight and improve their quality of life.
Eligibility
Inclusion Criteria1
- Patients with EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes and/or ferrochelatase mutation)- Fitzpatrick skin types I to IV.
Exclusion Criteria1
- Any other photodermatosis such as polymorphic light eruption (PLE), discoid lupus erythematosus (DLE) or solar urticaria- females who are pregnant, lactating or of child bearing age not using adequate methods of contraception- 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).- History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurological, haematological or systemic disease judged to be clinically significant by the Investigator.
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Interventions
CUV1647 (20 mg implant) every two months for a total of 12 months. Patients will serve as their own contols for all tested parameters.
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000535572