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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04578496 |
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Date of registration:
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05/10/2020 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
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Scientific title:
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A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) |
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Date of first enrolment:
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July 11, 2011 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04578496 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Contacts
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Name:
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Pilar Bilbao |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinuvel Pharmaceuticals Limited |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male or female subjects with a positive diagnosis of EPP who successfully completed
the CUV017 or CUV029 studies;
- aged 18-75 years (inclusive);
- provide written informed patient consent prior to the performance of any
study-specific procedure.
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 (confirmed by positive serum ß-Human Chorionic Gonadotropin
(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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Erythropoietic Protoporphyria
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Intervention(s)
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Drug: Afamelanotide
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Primary Outcome(s)
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Change in Quality of Life Measured Using the EPP-quality of Life Questionnaire (EPP-QoL).
[Time Frame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)]
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Change in Quality of Life Measured Using the Dermatology Life Quality Index Questionnaire (DLQI)
[Time Frame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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