Clinical Trials Logo

Erythropoietic Protoporphyria clinical trials

View clinical trials related to Erythropoietic Protoporphyria.

Filter by:

NCT ID: NCT06388642 Recruiting - Clinical trials for Erythropoietic Protoporphyria

Pharmacokinetics of Afamelanotide in EPP Patients

Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

NCT ID: NCT05883748 Enrolling by invitation - Clinical trials for Erythropoietic Protoporphyria

Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP

Start date: August 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.

NCT ID: NCT05780840 Recruiting - Clinical trials for Erythropoietic Protoporphyria

Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

Start date: February 23, 2023
Phase: N/A
Study type: Interventional

What is the visible light protective effect of dihydroxyacetone in individuals with erythropoietic protoporphyria? This will be tested in this randomized blinded placebo controlled study.

NCT ID: NCT05572125 Completed - Iron-deficiency Clinical Trials

Iron Therapy in Erythropoietic Protoporphyria

Start date: October 17, 2022
Phase:
Study type: Observational

Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.

NCT ID: NCT05308472 Active, not recruiting - Clinical trials for Erythropoietic Protoporphyria

Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP

Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP. Participants may roll over to an open label extension portion after completing the double-blind treatment period.

NCT ID: NCT05020184 Recruiting - Clinical trials for Erythropoietic Protoporphyria

Effect of Oral Cimetidine in the Protoporphyrias

Start date: June 14, 2022
Phase: Phase 2
Study type: Interventional

Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic defects of heme biosynthesis that cause life-long, painful cutaneous sensitivity to light. The objective of this study is to determine the efficacy and safety of oral cimetidine administration for treatment of the protoporphyrias. Efficacy will be based on protoporphyrin levels, photosensitivity, and quality of life questionnaires. Funding Source- FDA OOPD

NCT ID: NCT04578496 Completed - Clinical trials for Erythropoietic Protoporphyria

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

Start date: July 11, 2011
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04053270 Completed - Clinical trials for Erythropoietic Protoporphyria

Multicentre Phase III Erythropoietic Protoporphyria Study

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP). The study was conducted with two parallel study arms with crossover between treatments every 60 days. Eligible patients were randomised to a treatment group, and received implants of active treatment (afamelanotide 16mg) or placebo, in an alternating crossover fashion according to the following dosing regime: - Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300 - Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300

NCT ID: NCT03682731 Completed - Clinical trials for Erythropoietic Protoporphyria

Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Start date: April 1, 2017
Phase:
Study type: Observational

Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.

NCT ID: NCT02979249 Completed - Clinical trials for Erythropoietic Protoporphyria

Oral Iron for Erythropoietic Protoporphyrias

EPP
Start date: December 2016
Phase: N/A
Study type: Interventional

In the medical literature there are conflicting reports on whether iron improves symptoms in patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of this study is to determine the effect of oral iron for EPP and XLP patients.