CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Afamelanotidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04578496
NCT04578496Phase 3Completed
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A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

Clinuvel Pharmaceuticals Limited·interventional·Posted Oct 8, 2020·Updated Nov 19, 2020

In Brief

A Phase 3 clinical trial evaluating Afamelanotide for Erythropoietic Protoporphyria. Completed, enrolled 16 participants.

Detailed Summary

The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythropoietic Protoporphyria
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2020
Enrollment StartJul 11, 2011
Primary CompletionFeb 27, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.7 years ago

Interventions

Afamelanotidedrug