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

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ClinicalTrials.gov Identifier: NCT00735969
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : September 16, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Marc Ghany, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Peginterferon
Drug: Ribavirin
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peginterferon and Ribavirin Arm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Peginterferon and Ribavirin Arm
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
55  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
4
  19.0%
Male
17
  81.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.
Hide Description [Not Specified]
Time Frame 24 weeks after treatment stop
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon and Ribavirin Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peginterferon and Ribavirin Arm
Hide Arm/Group Description 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.
All-Cause Mortality
Peginterferon and Ribavirin Arm
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Peginterferon and Ribavirin Arm
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon and Ribavirin Arm
Affected / at Risk (%) # Events
Total   2/21 (9.52%)    
Blood and lymphatic system disorders   
symptomatic anemia *  2/21 (9.52%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
EMail: mg228m@nih.gov
Layout table for additonal information
Responsible Party: Marc Ghany, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00735969    
Other Study ID Numbers: 080149
08-DK-0149 ( Other Identifier: NIH )
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: June 16, 2014
Results First Posted: September 16, 2014
Last Update Posted: October 20, 2014