Erythropoietic Protoporphyria Clinical Trial
Official title:
A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP)
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
Afamelanotide is a man-made drug being studied for use as a preventative medication for
Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of
human alpha melanocyte stimulating hormone (alpha-MSH).
The study will involve the use of an implant, which comes in the form of a small rod to be
administered under the skin. The implant may contain the study drug afamelanotide or a
placebo (inactive medication).
This study aims to provide insight into the effectiveness of afamelanotide under normal
conditions of use in EPP patients.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00979745 -
Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)
|
Phase 3 | |
Active, not recruiting |
NCT05308472 -
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP
|
Phase 2 | |
Completed |
NCT00004831 -
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
|
N/A | |
Completed |
NCT05572125 -
Iron Therapy in Erythropoietic Protoporphyria
|
||
Completed |
NCT01605136 -
Phase III Confirmatory Study in Erythropoietic Protoporphyria
|
Phase 3 | |
Completed |
NCT01422915 -
Sorbent Therapy of the Cutaneous Porphyrias
|
Phase 2/Phase 3 | |
Completed |
NCT00004940 -
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
|
Phase 3 | |
Recruiting |
NCT06388642 -
Pharmacokinetics of Afamelanotide in EPP Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT05020184 -
Effect of Oral Cimetidine in the Protoporphyrias
|
Phase 2 | |
Completed |
NCT01688895 -
Erythropoietic Protoporphyrias: Studies of the Natural History, Genotype-Phenotype Correlations, and Psychosocial Impact
|
||
Completed |
NCT04578496 -
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
|
Phase 3 | |
Recruiting |
NCT00206869 -
Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria
|
N/A | |
Recruiting |
NCT05780840 -
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
|
N/A | |
Completed |
NCT02979249 -
Oral Iron for Erythropoietic Protoporphyrias
|
N/A | |
Enrolling by invitation |
NCT05883748 -
Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP
|
Phase 2/Phase 3 | |
Completed |
NCT01097044 -
Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)
|
Phase 2 | |
Completed |
NCT03682731 -
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria
|