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

NCT ID: NCT00230854

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis C Hepatitis, Viral, Human

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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EMZ702

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OPKO Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandra Pastrak, M.D.

Role: STUDY_DIRECTOR

OPKO Health, Inc.

Locations

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L.H.S.C. University Campus

London, Ontario, Canada

Site Status

Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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IET-202

Identifier Type: -

Identifier Source: org_study_id

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