Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin
- Conditions
- Chronic Hepatitis CHepatitis, Viral, Human
- Registration Number
- NCT00230854
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Hepatitis C virus (HCV) genotype 1
- Previous therapy with pegylated interferon and ribavirin
- Documented previous treatment failure
- Hepatic dysfunction
- Coinfection with hepatitis B or HIV
- Other unrelated liver diseases
- Liver cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
- Secondary Outcome Measures
Name Time Method To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Trial Locations
- Locations (2)
L.H.S.C. University Campus
🇨🇦London, Ontario, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada