Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00107653
First received: April 6, 2005
Last updated: May 13, 2016
Last verified: May 2016
Results First Received: March 16, 2016  
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: Ribavirin
Drug: Peginterferon alfa-2a

  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 569 participants were recruited at 52 centers in the United States in the study conducted from 26 October 2004 and 07 September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 1038 screened participants, 569 were enrolled and 469 were screen failures because of eligibility criteria was not met. Of the 569 enrolled participants, 269 participants were assigned to Latino and 300 participants were assigned to non-Latino White group.

Reporting Groups
  Description
Latino Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
Non-Latino White Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Participant Flow:   Overall Study
    Latino     Non-Latino White  
STARTED     269     300  
COMPLETED     190     224  
NOT COMPLETED     79     76  
Adverse Event                 24                 43  
Insufficient Therapeutic Response                 25                 11  
Violation of Selection Criteria at Entry                 1                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 12                 13  
Lost to Follow-up                 13                 5  
Administrative Reasons                 3                 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.
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Reporting Groups
  Description
Latino Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
Non-Latino White Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Latino     Non-Latino White     Total  
Number of Participants  
[units: participants]
  269     300     569  
Age  
[units: Years]
Mean (Standard Deviation)
  45.6  (8.79)     48.1  (8.34)     46.9  (8.64)  
Gender  
[units: Participants]
     
Female     86     108     194  
Male     183     192     375  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response at Week 72   [ Time Frame: At Week 72 ]

2.  Secondary:   Percentage of Participants Achieving Virologic Response   [ Time Frame: At Weeks 4, 12, 24, 48, 60, and 72 ]

3.  Secondary:   Percentage of Participants With Early Virologic Response at Week 4   [ Time Frame: At Week 4 ]

4.  Secondary:   Percentage of Participants With Early Virologic Response at Week 12   [ Time Frame: At Week 12 ]

5.  Secondary:   Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time   [ Time Frame: From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72 ]

6.  Secondary:   Percentage of Participants With Biochemical Response   [ Time Frame: At Weeks 4, 12, 24, 48, 60 and 72 ]

7.  Secondary:   Percentage of Participants With ISHAK Histological Activity Index Response   [ Time Frame: At Week 72 ]

8.  Secondary:   Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72   [ Time Frame: From Baseline (Week 0) to Week 72 ]

9.  Secondary:   Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72   [ Time Frame: From Baseline (Week 0) to Week 72 ]

10.  Secondary:   Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score   [ Time Frame: At Week 72 ]

11.  Secondary:   Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72   [ Time Frame: From Baseline (Week 0) to Week 72 ]

12.  Secondary:   Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score   [ Time Frame: At Week 72 ]

13.  Secondary:   Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score   [ Time Frame: At Week 72 ]

14.  Secondary:   Mean Change From Baseline in Fat Score at Week 72   [ Time Frame: From Baseline (Week 0) to Week 72 ]

15.  Secondary:   Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72   [ Time Frame: From Baseline (Week 0) to Week 72 ]

16.  Secondary:   Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score   [ Time Frame: At Week 72 ]

17.  Secondary:   Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72   [ Time Frame: Baseline (Week 0), Week 48 and Week 72 ]

18.  Secondary:   Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72   [ Time Frame: Baseline (Week 0), Week 48 and Week 72 ]

19.  Secondary:   Number of Participants With Any Adverse Events and Serious Adverse Events   [ Time Frame: Up to Week 72 ]

20.  Secondary:   Number of Participants With Marked Abnormal Laboratory Parameters   [ Time Frame: Up to Week 72 ]

21.  Secondary:   Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities   [ Time Frame: Up 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00107653     History of Changes
Other Study ID Numbers: ML18179
Study First Received: April 6, 2005
Results First Received: March 16, 2016
Last Updated: May 13, 2016
Health Authority: United States: Food and Drug Administration