High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Ghany, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00735969
First received: August 14, 2008
Last updated: October 10, 2014
Last verified: October 2014
Results First Received: June 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Peginterferon
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
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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 and Ribavirin Arm Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.

Participant Flow:   Overall Study
    Peginterferon and Ribavirin Arm  
STARTED     21  
COMPLETED     21  
NOT COMPLETED     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.
Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin.

Reporting Groups
  Description
Peginterferon and Ribavirin Arm Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.

Baseline Measures
    Peginterferon and Ribavirin Arm  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 8  
Gender  
[units: participants]
 
Female     4  
Male     17  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures

1.  Primary:   Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.   [ Time Frame: 24 weeks after treatment stop ]


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


Results Point of Contact:  
Name/Title: High Dose Ribavirin in Combination With Peginterferon for Patients With Chronic Hepatitis C Genotype
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
phone: (301) 402-5115
e-mail: mg228m@nih.gov


Publications:

Responsible Party: Marc Ghany, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00735969     History of Changes
Other Study ID Numbers: 080149, 08-DK-0149
Study First Received: August 14, 2008
Results First Received: June 16, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration