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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00028093
Recruitment Status : Completed
First Posted : December 12, 2001
Results First Posted : November 8, 2013
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):
Yaron Rotman, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Peginterferon alfa-2a with Ribavirin
Drug: Peginterferon alfa-2a

  Participant Flow

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
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 

  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

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