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Status unknownNCT00332176Updated Apr 8, 2008

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 2 interventional study of Celgosivir and Celgosivir in Chronic Hepatitis C, sponsored by BioWest Therapeutics Inc. Status unknown at 3 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-08.

Sponsored by BioWest Therapeutics Inc · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • Hepatitis C
  • Celgosivir
  • HCV
  • Genotype 1
  • Treatment-naive
  • Early viral kinetics
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

BioWest Therapeutics Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients previously treated with Interferon-based therapy
  • patients with diabetes mellitus
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    1

    Drug: Celgosivir

  • Experimental
    2

    Drug: Celgosivir

  • Active comparator
    3

    Drug: Peginterferon alfa 2b + ribavirin

Interventions

  • DrugCelgosivir

    400mg qd + standard of care for 12 weeks

  • DrugCelgosivir

    600mg qd + standard of care for 12 weeks

  • DrugPeginterferon alfa 2b + ribavirin

    Standard of care for 12 weeks

06

What researchers measure

Primary outcomes

  1. Safety analysis

    Time frame: 12 weeks

  2. HCV viral load

    Time frame: 12 weeks

  3. Pharmacokinetics of celgosivir/castanospermine

    Time frame: 12 weeks

07

Study locations

2 of 3 sites recruiting
  • Liver and Intestinal Research Centre
    Vancouver, British Columbia V5Z 1H2, Canada
    Recruiting
  • Cantest
    Vancouver, British Columbia V5Z 1H6, Canada
    Completed
  • Biovail Contract Research
    Toronto, Ontario M1L 4S4, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00332176
Lead sponsor
BioWest Therapeutics Inc
First posted
Jun 1, 2006
Start date
Jun 2006
Primary completion
Dec 2008 (estimated)
Completion
Dec 2008 (estimated)
Last update
Apr 8, 2008

Study contacts

Jim Pankovich
Contact
604-221-9666 ext. 259
Jim Pankovich
study director · BioWest Therapeutics Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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