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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
    Peginterferon+Ribavirin     Peginterferon Alone     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: years]
Median ( Full Range )
  49  
  ( 35 to 68 )  
  52  
  ( 28 to 67 )  
  51  
  ( 28 to 68 )  
Gender  
[units: participants]
     
Female     11     15     26  
Male     14     10     24  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     17     21     38  
African American     4     2     6  
Asian     2     1     3  
Hispanic     2     1     3  
Duration of infection  
[units: year]
Mean ± Standard Deviation
  23  ± 9.0     23  ± 7.7     23  ± 8.4  
Mode of infection  
[units: participants]
     
Injection drug use     10     8     18  
Blood transfusion     8     9     17  
Other     5     6     11  
Unknown     2     2     4  
Weight  
[units: kg]
Mean ± Standard Deviation
  78.1  ± 17     76.8  ± 19     77.5  ± 18.0  
Body Mass Index  
[units: kg/(m^2)]
Mean ± Standard Deviation
  26.9  ± 4.9     27.0  ± 4.8     27.0  ± 4.9  
Alanine transaminase  
[units: U/L]
Mean ± Standard Deviation
  69  ± 61     96  ± 79     83  ± 71  
Ishak fibrosis [1]
[units: participant]
     
0-2     15     16     31  
3-6     10     9     19  
Histology activity index [2]
[units: Units on a scale]
Median ( Full Range )
  8  
  ( 5 to 13 )  
  8  
  ( 3 to 15 )  
  8  
  ( 3 to 15 )  
Hepatitis C Virus RNA level  
[units: log(IU/mL)]
Mean ± Standard Deviation
  6.2  ± 0.53     6.2  ± 0.58     6.2  ± 0.56  
[1] Fibrosis was staged with the Ishak scale (ranging from 0 = no fibrosis to 6 = cirrhosis). Higher values represent a worse outcome.
[2] Possible range 0-18. Higher values represent a worse outcome.



  Outcome Measures

1.  Primary:   Change in Hepatitis C Virus RNA Levels During Phase I   [ Time Frame: From day 0 to day 3 ]
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Measure Type Primary
Measure Title Change in Hepatitis C Virus RNA Levels During Phase I
Measure Description No text entered.
Time Frame From day 0 to day 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peginterferon+Ribavirin No text entered.
Peginterferon No text entered.

Measured Values
    Peginterferon+Ribavirin     Peginterferon  
Number of Participants Analyzed  
[units: participants]
  24     24  
Change in Hepatitis C Virus RNA Levels During Phase I  
[units: log(IU/mL)]
Median ( Full Range )
  0.50  
  ( -0.40 to 2.30 )  
  0.70  
  ( -0.10 to 1.70 )  


Statistical Analysis 1 for Change in Hepatitis C Virus RNA Levels During Phase I
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: there is no difference in the outcome between the two groups
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Combination of Pegylated Interferon and Ribavirin as Therapy for Patients With Chronic Hepatitis C W
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
phone: 3014961333
e-mail: hoofnaglej@extra.niddk.nih.gov


Publications:

Responsible Party: Yaron Rotman, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00028093     History of Changes
Other Study ID Numbers: 020065, 02-DK-0065
Study First Received: December 11, 2001
Results First Received: May 26, 2011
Last Updated: September 4, 2013
Health Authority: United States: Federal Government