A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Celgosivir

Intervention Type DRUG

400mg qd + standard of care for 12 weeks

2

Group Type EXPERIMENTAL

Celgosivir

Intervention Type DRUG

600mg qd + standard of care for 12 weeks

3

Group Type ACTIVE_COMPARATOR

Peginterferon alfa 2b + ribavirin

Intervention Type DRUG

Standard of care for 12 weeks

Interventions

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Celgosivir

400mg qd + standard of care for 12 weeks

Intervention Type DRUG

Celgosivir

600mg qd + standard of care for 12 weeks

Intervention Type DRUG

Peginterferon alfa 2b + ribavirin

Standard of care for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age, inclusive
* primary diagnosis of chronic HCV infection, genotype 1
* Interferon-based treatment-naïve
* Body Mass Index of 18 to 30, inclusive