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

BioWest Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa 2b + ribavirin; Drug: Celgosivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332176

HCV-06-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• patients previously treated with Interferon-based therapy
• patients with diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Celgosivir

Drug: Celgosivir

2

Experimental group

Treatment:

Drug: Celgosivir

Drug: Celgosivir

3

Active Comparator group

Treatment:

Drug: Peginterferon alfa 2b + ribavirin