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

A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332176

Enrollment

Registered

2006-06-01

Start date

2006-06-30

Completion date

2008-12-31

Last updated

2008-04-08

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

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C, Celgosivir, HCV, Genotype 1, Treatment-naive, Early viral kinetics

Brief summary

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.

Interventions

DRUGCelgosivir

400mg qd + standard of care for 12 weeks

DRUGPeginterferon alfa 2b + ribavirin

Standard of care for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Safety analysis	12 weeks
HCV viral load	12 weeks
Pharmacokinetics of celgosivir/castanospermine	12 weeks

Countries

Canada

Contacts

Primary ContactJim Pankovich

604-221-9666

Outcome results

None listed

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