Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin

OPKO Health

Status and phase: Completed; Phase 1

Conditions: Hepatitis, Viral, Human; Chronic Hepatitis C

Treatments: Drug: EMZ702

Study type: Interventional

Funder types: Industry

Identifiers

NCT00230854

IET-202

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1.

Full description

In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous treatment with pegylated interferon plus ribavirin will be treated. The study treatment will consist of the same type and doses of pegylated interferon and ribavirin to which the patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during the first 12 weeks of treatment. Thereafter and according to viral response, patients will continue to receive pegylated interferon and ribavirin only for up to 36 weeks.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hepatitis C virus (HCV) genotype 1
• Previous therapy with pegylated interferon and ribavirin
• Documented previous treatment failure

Exclusion criteria

• Hepatic dysfunction
• Coinfection with hepatitis B or HIV
• Other unrelated liver diseases
• Liver cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)