NCT00217139

Brief Summary

The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

September 29, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 27, 2006

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis CCelgosivirHCVGenotype 1Non-respondersEarly Viral ResponseEVR

Outcome Measures

Primary Outcomes (2)

  • Safety analysis

  • HCV viral load

Interventions

CelgosivirDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, inclusive
  • primary diagnosis of chronic HCV infection
  • non-responders to previous pegylated interferon-based therapy

You may not qualify if:

  • patients naive to interferon-based therapy for chronic HCV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

celgosivir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jim Pankovich

    BioWest Therapeutics Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

September 29, 2006

Record last verified: 2006-09

Locations

CA(6)