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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000535572

Enrollment

Registered

2006-12-22

Start date

2006-09-01

Completion date

2006-10-10

Last updated

2022-06-20

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

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients with EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes and/or ferrochelatase mutation)- Fitzpatrick skin types I to IV.

Exclusion criteria

Any other photodermatosis such as polymorphic light eruption (PLE), discoid lupus erythematosus (DLE) or solar urticaria- females who are pregnant, lactating or of child bearing age not using adequate methods of contraception- Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.- Acute history of drug or alcohol abuse (in the last 12 months).- History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurological, haematological or systemic disease judged to be clinically significant by the Investigator.

Outcome results