Status:
COMPLETED
Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Erythropoietic Protoporphyria
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH)...
Detailed Description
PURPOSE: To determine whether afamelanotide can reduce the severity of phototoxic reactions in patients with EPP. THEORETICAL FRAMEWORK: EPP is a genetic photosensitivity disorder where the mainsta...
Eligibility Criteria
Inclusion
- Male or female subjects 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 (inclusive)
- Written informed consent prior to the performance of any study-specific procedures.
Exclusion
- Any allergy to afamelanotide or the polymer contained in the implant or to lignocaine or other local anaesthetic to be 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.
- 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).
- 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 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).
- 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 of an 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, including drugs that cause photosensitivity or skin pigmentation.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00979745
Start Date
September 1 2009
End Date
May 1 2011
Last Update
October 12 2021
Active Locations (8)
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1
HUS:n Iho-ja allergiasairaala (Skin and Allergy Hospital)
Helsinki, Finland
2
Centre Français des Porphyries, Hôpital Louis Mourier
Colombes, Cedex, France, 92701
3
Department of Dermatology , Heinrich-Heine-University Duesseldorf
Düsseldorf, Germany, 40225
4
Beaumont Hospital, Department of Dermatology
Dublin, Ireland, 9