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Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaron Rotman, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00028093
First received: December 11, 2001
Last updated: September 4, 2013
Last verified: May 2013
Results First Received: May 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Peginterferon alfa-2a with Ribavirin
Drug: Peginterferon alfa-2a

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Peginterferon+Ribavirin peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
Peginterferon Alone peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.

Participant Flow:   Overall Study
    Peginterferon+Ribavirin     Peginterferon Alone  
STARTED     25     25  
COMPLETED     25     25  
NOT COMPLETED     0     0  



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Change in Hepatitis C Virus RNA Levels During Phase I   [ Time Frame: From day 0 to day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information