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NCT00230854 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
An Open Label, Dose Escalation Study of EMZ702 in Combination With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Non-responsive to Prior Therapy With Pegylated Interferon and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00230854
Other study ID # IET-202
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2005
Est. completion date July 2007

Study information
Verified date October 2019
Source OPKO Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 28
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• EMZ702

Locations
Country Name City State
Canada L.H.S.C. University Campus London Ontario
Canada Ottawa Hospital Ottawa Ontario

Sponsors (1)
Lead Sponsor Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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