Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT00056862
First received: March 25, 2003
Last updated: November 13, 2013
Last verified: November 2013
Results First Received: November 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin

  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
Between Dec 2003 and Dec 2004, 31 patients were enrolled into the low-dose group and were treated with peginterferon alfa-2a 90ug/week and ribavirin 400 mg/twice daily for 24 week. From Feb 2005, all subsequent patients were enrolled into a standard-dose group and treated for 24 weeks with the doses of the approved regimen.

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
Low Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
Standard Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.

Participant Flow:   Overall Study
    Low Dose Group     Standard Dose Group  
STARTED     31     27  
COMPLETED     30     27  
NOT COMPLETED     1     0  
Protocol Violation                 1                 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
Low Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
Standard Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Total Total of all reporting groups

Baseline Measures
    Low Dose Group     Standard Dose Group     Total  
Number of Participants  
[units: participants]
  30     27     57  
Age  
[units: years]
Mean ( Full Range )
  48  
  ( 29 to 62 )  
  47  
  ( 26 to 69 )  
  48  
  ( 26 to 69 )  
Gender  
[units: participants]
     
Female     15     14     29  
Male     15     13     28  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     26     20     46  
Asian     2     5     7  
Hispanic     1     0     1  
African-American     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     30     27     57  
ALT  
[units: U/L]
Mean ± Standard Deviation
  91  ± 69     97  ± 85     94  ± 77  
HCV RNA  
[units: logĀ IU/mL]
Mean ± Standard Deviation
  6.3  ± 0.82     5.9  ± 1.02     6.1  ± 0.92  
Genotype  
[units: participants]
     
HCV Genotype 2     21     13     34  
HCV Genotype 3     9     14     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Virological Response (Intention to Treat)   [ Time Frame: 6 months after stopping therapy ]

2.  Primary:   Virological Response Category (Per Protocol)   [ Time Frame: 6 months after therapy ]

3.  Secondary:   First Phase Decline in Logarithm of HCV RNA Level   [ Time Frame: 2 days ]

4.  Secondary:   Slope of Second Phase Decline in HCV Levels   [ Time Frame: day 7 to day 28 ]

5.  Secondary:   Time to Negativity   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 72 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   3%  

Reporting Groups
  Description
Low Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
Standard Dose Group All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.

Other Adverse Events
    Low Dose Group     Standard Dose Group  
Total, other (not including serious) adverse events      
# participants affected / at risk     2/30     1/27  
Blood and lymphatic system disorders      
Sarcoidosis development    
# participants affected / at risk     1/30 (3.33%)     0/27 (0.00%)  
# events     1     0  
Severe hemolysis requiring transfusion    
# participants affected / at risk     0/30 (0.00%)     1/27 (3.70%)  
# events     0     1  
Cardiac disorders      
Atrial fibrillation (off treatment),    
# participants affected / at risk     1/30 (3.33%)     0/27 (0.00%)  
# events     1     0  
Events were collected by systematic assessment



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


Results Point of Contact:  
Name/Title: Jay H. Hoofnagle, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
phone: 3014961333
e-mail: hoofnaglej@extra.niddk.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00056862     History of Changes
Other Study ID Numbers: 030136, 03-DK-0136
Study First Received: March 25, 2003
Results First Received: November 12, 2010
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration