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Clinical Trials/EUCTR2007-000636-13-GB
EUCTR2007-000636-13-GB
Active, not recruiting
Phase 1

A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study

Clinuvel Pharmaceuticals Limited0 sites80 target enrollmentFebruary 29, 2008
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Clinuvel Pharmaceuticals Limited
Enrollment
80
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 29, 2008
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Male or female subjects with a positive diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes)
  • •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

  • •\-Allergy to CUV1647 or the polymer contained in the implant or to lignocaine or other local anaesthetic to be used during the administration of the study medication
  • •\-Any other photodermatosis such as PLE, DLE or solar urticaria.
  • •\-Female who is pregnant, lactating or of childbearing potential and not using adequate form(s) of contraception.
  • •\-Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.
  • •\-Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
  • •\-Personal history of melanoma or dysplastic nevus syndrome.

Outcomes

Primary Outcomes

Not specified

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