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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 April 2012 |
Main ID: |
EUCTR2009-011018-51-FI |
Date of registration:
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20/04/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2
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Scientific title:
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A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 |
Date of first enrolment:
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18/08/2009 |
Target sample size:
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70 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011018-51 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Finland
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Ireland
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Netherlands
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: To be eligible to enter the study, patients must meet the following inclusion criteria: - Male or female subjects with a positive diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes) - Aged 18-70 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: To be eligible to enter the study, patients must not meet any of the following exclusion criteria: - Allergy to afamelanotide or the polymer contained in the implant or 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 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 ß-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 for 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1
Level: LLT
Classification code 10015289
Term: Erythropoietic protoporphyria
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Intervention(s)
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Product Name: afamelanotide Product Code: CUV1647 Pharmaceutical Form: Implant Pharmaceutical form of the placebo: Implant Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): -Efficacy Endpoints: Efficacy will be assessed by: - Number and severity of phototoxic reactions - Quality of life measured with DLQI questionnaire and supplementary EPP specific questions - Free protoporphyrin IX in peripheral erythrocytes
Safety and Tolerability Endpoints: Treatment-emergent adverse events (coded as MedDRA Preferred Terms). Changes in hematology, serum chemistry and urinalysis measurements from Screening to Study Days 60, 120 and 180.
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Secondary Objective: - To determine whether afamelanotide can reduce the number of phototoxic reactions in patients with EPP - To evaluate the safety and tolerability of afamelanotide by measuring treatment-emergent adverse events (AEs) - To determine whether afamelanotide can improve the quality of life of EPP patients - To determine the effect of afamelanotide on free protoporphyrin IX levels
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Main Objective: To determine whether afamelanotide can reduce the severity of phototoxic reactions in patients with EPP.
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Secondary ID(s)
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2009-011018-51-NL
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CUV029
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N/A
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Source(s) of Monetary Support
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Results
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Results available:
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