Status:
COMPLETED
Multicentre Phase III Erythropoietic Protoporphyria Study
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Erythropoietic Protoporphyria
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythro...
Detailed Description
Afamelanotide is a man-made drug being studied for use as a preventative medication for Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of human alpha melanocyte...
Eligibility Criteria
Inclusion
- Male or female patients with a diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes) of sufficient severity that they have requested treatment to alleviate their symptoms.
- Aged 18-70 years.
- Written informed consent prior to the performance of any study-specific procedure.
Exclusion
- Any allergy to afamelanotide or the polymer contained in the implant or to lignocaine or other local anaesthetic used during the administration of 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 other photodermatosis such as PLE, DLE or solar urticaria.
- Diagnosed with HIV/AIDS or hepatitis.
- 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 (including diabetes, Cushing's syndrome, Addison's disease, Peutz-Jeagher syndrome), neurological (including seizures), haematological (especially anaemia of less than 10 g/100 mL) or systemic disease judged to be clinically significant by the Investigator.
- Major medical or psychiatric illness
- Patient assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history allergic to local anaesthetics, faints when given injections or giving blood).
- Female who was 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).
- Participation in a clinical trial of an investigational agent within 30 days prior to the screening visit.
- Use of regular medications as specified in protocol Section 5.4 Prior and Concomitant Therapy.
- Any factors that may affect skin reflectance measurements.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04053270
Start Date
May 1 2007
End Date
December 9 2009
Last Update
October 10 2019
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