A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000261415

Enrollment

Registered

2007-05-15

Start date

2007-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if there is a difference between the number and severity of phototoxic reactions that occurr in patients with Erythropoietic Protoporphyria (EPP) treated with CUV1647 and placebo.

Interventions

CUV1647 (16 mg/implant) contained in a poly(D,L-lactide-co-glycolide) implant core. The implant is fully bioresorbable and implanted subcutaneously. Drug is released from the active implant over 10 to 15 days. The study design consists of two parallel study arms with crossover between treatments every 60 days for 360 days. There is no wash out period in this study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Subjects with a positive diagnosis of EPP

Exclusion criteria

EPP patients with significant hepatic involvement Any other photodermatosis

Outcome results