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Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Viramidine
Ribavirin
pegylated interferon alfa-2b
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2b

Eligibility Criteria

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

Inclusion Criteria: Treatment-naive patients with compensated chronic hepatitis C. HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: Severe neuropsychiatric disorders History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, opthalmologic disorders including severe retinopathy, or immune mediated disease Pregnant or breast-feeding patients

Sites / Locations

    Outcomes

    Primary Outcome Measures

    - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
    - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.

    Secondary Outcome Measures

    - Efficacy: Undetectable plasma HCV RNA at treatment week 24
    - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
    - Safety: Monitoring of adverse events
    - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related

    Full Information

    First Posted
    September 29, 2005
    Last Updated
    June 21, 2012
    Sponsor
    Bausch Health Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00230958
    Brief Title
    Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive
    Official Title
    Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.
    Detailed Description
    Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C
    Keywords
    Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2b

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    900 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Viramidine
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated interferon alfa-2b
    Primary Outcome Measure Information:
    Title
    - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
    Title
    - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
    Secondary Outcome Measure Information:
    Title
    - Efficacy: Undetectable plasma HCV RNA at treatment week 24
    Title
    - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
    Title
    - Safety: Monitoring of adverse events
    Title
    - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Treatment-naive patients with compensated chronic hepatitis C. HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: Severe neuropsychiatric disorders History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, opthalmologic disorders including severe retinopathy, or immune mediated disease Pregnant or breast-feeding patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ralph T. Doyle
    Organizational Affiliation
    Bausch Health Americas, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive

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