MedTrace Logo

A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

NCT04578496 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-19

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Afamelanotide

Sponsors & Collaborators

  • Clinuvel Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Pilar Bilbao · Clinuvel Pharmaceuticals Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-11
Primary Completion
2014-02-27
Completion
2014-02-27

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578496 on ClinicalTrials.gov