A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

NCT ID: NCT00217139

Last Updated: 2006-09-29

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Keywords

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Hepatitis C Celgosivir HCV Genotype 1 Non-responders Early Viral Response EVR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Celgosivir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age, inclusive
* primary diagnosis of chronic HCV infection
* non-responders to previous pegylated interferon-based therapy

Exclusion Criteria

* patients naive to interferon-based therapy for chronic HCV infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioWest Therapeutics Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jim Pankovich

Role: STUDY_DIRECTOR

BioWest Therapeutics Inc

Locations

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Calgary, Alberta, Canada

Site Status

Edmonton, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Winnipeg, Manitoba, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HCV-05-002

Identifier Type: -

Identifier Source: org_study_id