A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800735
First received: October 23, 2008
Last updated: September 30, 2013
Last verified: September 2013
Results First Received: July 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Pegylated-interferon 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
No text entered.

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
Pegylated-interferon Alfa-2a Plus Ribavirin Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.

Participant Flow:   Overall Study
    Pegylated-interferon Alfa-2a Plus Ribavirin  
STARTED     30  
COMPLETED     16  
NOT COMPLETED     14  
Administrative/Other                 2  
Insufficient Therapeutic Response                 2  
Violation of Selection Criteria at Entry                 7  
Withdrew Consent                 3  



  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
Pegylated-interferon Alfa-2a Plus Ribavirin Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.

Baseline Measures
    Pegylated-interferon Alfa-2a Plus Ribavirin  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  48.5  ± 9.35  
Gender  
[units: participants]
 
Female     18  
Male     12  
Race/Ethnicity, Customized  
[units: participants]
 
Black     2  
Caucasian     28  
Height  
[units: cm]
Mean ± Standard Deviation
  170.0  ± 7.28  
Weight  
[units: kg]
Mean ± Standard Deviation
  76.97  ± 16.146  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  26.5  ± 4.53  



  Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced at Least 1 Adverse Event.   [ Time Frame: Baseline through 24 weeks after the end of treatment (up to 72 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  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.


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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Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800735     History of Changes
Other Study ID Numbers: NV21928, 2008-002022-10
Study First Received: October 23, 2008
Results First Received: July 5, 2013
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration