NCT00292084

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.

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 Feb 2006

Geographic Reach
1 country

1 active site

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

February 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 21, 2008

Status Verified

January 1, 2008

First QC Date

February 13, 2006

Last Update Submit

January 17, 2008

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis CCelgosivirHCVGenotype 1Non-respondersEnd of Treatment ResponseSustained Viral Response

Outcome Measures

Primary Outcomes (2)

  • Safety analysis

  • HCV viral load reduction from baseline

Interventions

CelgosivirDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who completed HCV-05-002 only
  • 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 (1)

Unknown Facility

Halifax, Nova Scotia, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

February 1, 2006

Study Completion

October 1, 2007

Last Updated

January 21, 2008

Record last verified: 2008-01

Locations

CA(1)