NCT00292084

CompletedPhase 2

An Extension Study to Evaluate the Safety and Efficacy of Ce...

BioWest Therapeutics Inc Source

BioWest Therapeutics Inc

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

HCV-05-004

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

February 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: October 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 13, 2006
Actual (reported)
First Posted
February 15, 2006
Actual (reported)
Study Completion
October 2007
Actual (reported)

Last Updated: January 21, 2008
Status Verified: January 2008
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

BioWest Therapeutics Inc
Industrylead

Study Sites (1)

Halifax, Nova Scotia, Canada

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 Diseases

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 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2007

Actual (reported)

Phase 2Completed

NCT00446134

Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)

Phase 2Completed

NCT00495391

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Phase 2Completed

NCT00418054

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Phase 2Completed

NCT00160251

Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

Phase 2Completed

NCT00115908

A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

Phase 2Completed

NCT00556504

The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection

Phase 2Completed

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.

Chronic Disease

Disease Attributes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Last Updated

January 21, 2008

Record last verified: 2008-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00292084
Data provider: ClinicalTrials.gov
Source updated: 2008-01-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:49 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations