Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00081770
First received: April 20, 2004
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: November 3, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: REBETOL (ribavirin; SCH 18908)
Biological: PEGASYS (peginterferon alfa-2a)
Drug: COPEGUS (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
Enrolled 4469 subjects; Randomized 3083; Treated 3070

Reporting Groups
  Description
PegIntron 1.5 ug/kg/wk Plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk Plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up

Participant Flow:   Overall Study
    PegIntron 1.5 ug/kg/wk Plus REBETOL     PegIntron 1.0 ug/kg/wk Plus REBETOL     PEGASYS 180 ug/wk Plus COPEGUS  
STARTED     1019     1016     1035  
COMPLETED     517 [1]   470 [1]   579 [1]
NOT COMPLETED     502     546     456  
Adverse Event                 130                 98                 136  
Lack of Efficacy                 262                 357                 211  
Lost to Follow-up                 45                 34                 45  
Protocol Violation                 15                 10                 10  
Withdrawal by Subject                 45                 40                 42  
Did not meet protocol eligibility                 2                 0                 3  
Administrative                 1                 0                 1  
Not Specified                 2                 7                 8  
[1] Patients who discontinued treatment but continued in study are considered Not Completed



  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
PegIntron 1.5 ug/kg/wk Plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk Plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Total Total of all reporting groups

Baseline Measures
    PegIntron 1.5 ug/kg/wk Plus REBETOL     PegIntron 1.0 ug/kg/wk Plus REBETOL     PEGASYS 180 ug/wk Plus COPEGUS     Total  
Number of Participants  
[units: participants]
  1019     1016     1035     3070  
Age  
[units: years]
Mean ± Standard Deviation
  47.5  ± 7.8     47.5  ± 8.1     47.6  ± 8.2     47.5  ± 8.0  
Gender  
[units: participants]
       
Female     406     409     422     1237  
Male     613     607     613     1833  



  Outcome Measures
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1.  Primary:   Sustained Virologic Response (SVR) Rate   [ Time Frame: Assessed at the end of a 24-week post-treatment follow-up ]

2.  Secondary:   Mean Change From Baseline in the Log Viral Load at Treatment Week 4   [ Time Frame: Assessed at Baseline and Treatment Week 4 ]

3.  Secondary:   Virologic Response Rate at Treatment Week 12   [ Time Frame: Assessed at Treatment Week 12 ]

4.  Secondary:   Mean Change From Baseline in the Log Viral Load at Treatment Week 2   [ Time Frame: Assessed at Baseline and Treatment Week 2 ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00081770     History of Changes
Other Study ID Numbers: P03471, 2552898
Study First Received: April 20, 2004
Results First Received: November 3, 2008
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration