An Extension 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

A Phase II, Multi-Center, Extension Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With or Without Ribavirin, for an Additional 36 Weeks

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00292084

Enrollment

Registered

2006-02-15

Start date

2006-02-28

Completion date

2007-10-31

Last updated

2008-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Celgosivir, HCV, Genotype 1, Non-responders, End of Treatment Response, Sustained Viral Response

Brief summary

This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.

Interventions

DRUGCelgosivir

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients who completed HCV-05-002 only * 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

Design outcomes

Primary

Measure	Time frame
Safety analysis	—
HCV viral load reduction from baseline	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026