TerminatedPhase 2ACTRN12606000535572

Phase II Study of CUV1647 in Erythropoietic Protoporphyria (EPP)

A Multicentre, Phase II, Open Label Study to Evaluate the Safety of CUV1647 and to Evaluate the Effect of Subcutaneous Implants of CUV1647 on the Time to Artificially Provoked Symptoms in Patients with Erythropoietic Protoporphyria (EPP)

Sponsor

Clinuvel Pharmaceuticals

Enrollment

10 participants

Start Date

Sep 1, 2006

Study Type

Interventional

Conditions

Erythropoietic Protoporphyria (EPP)

Summary

The study is intended to determine if CUV1647 can increase the tolerance of patients with EPP to sunlight and improve their quality of life.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase II study tests a drug called CUV1647 for people with erythropoietic protoporphyria (EPP), a rare condition that causes extreme sensitivity to sunlight. It is for adults aged 18-70 with confirmed EPP and Fitzpatrick skin types I to IV. Participants cannot be pregnant, have other sun-sensitivity disorders, or have significant organ problems.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

CUV1647 (20 mg implant) every two months for a total of 12 months. Patients will serve as their own contols for all tested parameters.

Locations(1)

Switzerland

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12606000535572

Related Trials

Observational Study of Adults and Adolescents With Erythropoietic Protoporphyria (EPP) and X-linked Porphyria (XLP)

NCT0756713119 locations

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

NCT0691035828 locations