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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 12, 2001
Last Update Posted: November 8, 2013
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.
Information provided by (Responsible Party):
Yaron Rotman, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: May 26, 2011  
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

  Baseline Characteristics
  Hide Baseline Characteristics

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.
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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.
Total Total of all reporting groups

Baseline Measures
   Peginterferon+Ribavirin   Peginterferon Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
[Units: Years]
Median (Full Range)
 (35 to 68) 
 (28 to 67) 
 (28 to 68) 
[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 
[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 
[1] Fibrosis was staged with the Ishak scale (ranging from 0 = no fibrosis to 6 = cirrhosis). Higher values represent a worse outcome.
Histology activity index [1] 
[Units: Units on a scale]
Median (Full Range)
 (5 to 13) 
 (3 to 15) 
 (3 to 15) 
[1] Possible range 0-18. Higher values represent a worse outcome.
Hepatitis C Virus RNA level 
[Units: log(IU/mL)]
Mean (Standard Deviation)
 6.2  (0.53)   6.2  (0.58)   6.2  (0.56) 

  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
  Hide 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
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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


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 ( Other Identifier: NIH Clinical Center )
First Submitted: December 11, 2001
First Posted: December 12, 2001
Results First Submitted: May 26, 2011
Results First Posted: November 8, 2013
Last Update Posted: November 8, 2013