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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077649
First received: February 10, 2004
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: February 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: ribavirin [Copegus]
Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

  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 188 participants were enrolled in the study which was conducted at 23 centers in the United States from 13 January 2004 to 06 December 2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of participants who completed and did not complete the 48 weeks of treatment are presented in the table .

Reporting Groups
  Description
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.

Participant Flow:   Overall Study
    PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg     PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg     PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg     PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg  
STARTED     47     47     47     47  
Completed 24 Weeks of Follow-up     36     40     36     31  
COMPLETED     33     38     32     30  
NOT COMPLETED     14     9     15     17  
Adverse Event                 5                 1                 7                 9  
Lack of Efficacy                 5                 3                 3                 2  
Withdrawal by Subject                 0                 1                 1                 2  
Lost to Follow-up                 2                 2                 3                 2  
Abnormality of Laboratory Test                 1                 2                 1                 2  
Randomized but never dosed                 1                 0                 0                 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.
The ITT [intent to treat] population which consisted of all participants who were randomized and received at least one dose of either of the study medication

Reporting Groups
  Description
PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg     PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg     PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg     PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg     Total  
Number of Participants  
[units: participants]
  47     47     47     47     188  
Age  
[units: years]
Mean (Standard Deviation)
  47.2  (7.48)     49.6  (8.46)     47.1  (6.37)     48.5  (6.78)     48.1  (7.33)  
Gender  
[units: participants]
         
Female     9     6     12     10     37  
Male     38     41     35     37     151  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HCV RNA Profile During The First 24 Weeks   [ Time Frame: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24 ]

2.  Primary:   Percentage of Participants With Virological Response Over Time to Week 24   [ Time Frame: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24 ]

3.  Primary:   Percentage of Participants With Predicted Sustained Virological Response   [ Time Frame: Week 4 and 12 ]

4.  Secondary:   Percentage of Participants With Sustained Virological Response   [ Time Frame: Week 72 ]

5.  Secondary:   Percentage of Participants With Virological Response at the End of the Treatment Period   [ Time Frame: Week 48 ]

6.  Secondary:   Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period   [ Time Frame: Week 60 ]

7.  Secondary:   Percentage of Participants With Adverse Events and Serious Adverse Events   [ Time Frame: Up to Week 72 ]

8.  Secondary:   Percentage of Participants With Marked Laboratory Abnormalities   [ Time Frame: Up to Week 60 ]

9.  Secondary:   Percentage of Participants With Abnormal Vital Signs   [ Time Frame: Up to Week 72 ]

10.  Secondary:   Total BDI-II (Beck Depression Inventory) Scores   [ Time Frame: From Baseline (Day 1) to 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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077649     History of Changes
Other Study ID Numbers: NV17318
Study First Received: February 10, 2004
Results First Received: February 3, 2016
Last Updated: March 21, 2016
Health Authority: United States: Food and Drug Administration