A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922779
First received: June 16, 2009
Last updated: December 11, 2015
Last verified: December 2015
Results First Received: December 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: peginterferon alfa-2a [Pegasys]
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
A total of 7799 participants were screened, of which 6661 participants were included in the study.

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
Ribavirin + Peginterferon Alfa-2a Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.

Participant Flow:   Overall Study
    Ribavirin + Peginterferon Alfa-2a  
STARTED     6661  
COMPLETED     4334  
NOT COMPLETED     2327  
Adverse Event                 67  
Pregnancy                 7  
Withdrawal by Subject                 308  
Lost to Follow-up                 44  
Unspecified                 27  
Missing                 1874  



  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.
Baseline population included all enrolled participants.

Reporting Groups
  Description
Ribavirin + Peginterferon Alfa-2a Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.

Baseline Measures
    Ribavirin + Peginterferon Alfa-2a  
Number of Participants  
[units: participants]
  6661  
Age [1]
[units: Years]
Mean (Standard Deviation)
  34.21  (9.81)  
Gender, Customized  
[units: Participants]
 
Male     4396  
Female     2250  
Missing     15  
[1] Here, number of participants analyzed for baseline measure "age" was 6622.



  Outcome Measures
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1.  Primary:   Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)   [ Time Frame: From signing of informed consent up to end of study (up to Week 72) ]

2.  Secondary:   Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy   [ Time Frame: 24 weeks after end of therapy (Week 72) ]

3.  Secondary:   Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation   [ Time Frame: Weeks 12,24 and 48 After Therapy Initiation ]

4.  Secondary:   Percentage of Participants With Change in Hemoglobin Level   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922779     History of Changes
Other Study ID Numbers: ML16709
Study First Received: June 16, 2009
Results First Received: December 11, 2015
Last Updated: December 11, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation