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A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Celgosivir
Sponsored by
BioWest Therapeutics Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Celgosivir, HCV, Genotype 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient must be 18 to 65 years of age, inclusive. Primary diagnosis of chronic HCV infection. Exclusion Criteria: Patients who did not respond or relapsed following therapy with interferon.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety analysis

    Secondary Outcome Measures

    Hepatitis C viral load

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    September 7, 2005
    Sponsor
    BioWest Therapeutics Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157534
    Brief Title
    A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection
    Official Title
    A Phase II, Randomised, Dose-Ranging, Open-Label, Multi-Centre Study to Evaluate the Safety and Efficacy of Celgosivir for 12 Weeks in Patients With Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    BioWest Therapeutics Inc

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic
    Keywords
    Hepatitis C, Celgosivir, HCV, Genotype 1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Celgosivir
    Primary Outcome Measure Information:
    Title
    Safety analysis
    Secondary Outcome Measure Information:
    Title
    Hepatitis C viral load

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient must be 18 to 65 years of age, inclusive. Primary diagnosis of chronic HCV infection. Exclusion Criteria: Patients who did not respond or relapsed following therapy with interferon.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jim Pankovich
    Organizational Affiliation
    BioWest Therapeutics Inc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

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