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Clinical Trials/EUCTR2007-000636-13-DE
EUCTR2007-000636-13-DE
Active, not recruiting
Not Applicable

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 enrollmentNovember 12, 2008
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Overview

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

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 12, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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