An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667432
First received: August 15, 2012
Last updated: November 3, 2015
Last verified: November 2015
Results First Received: October 1, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis B, Chronic
Intervention: Biological: 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
No text entered.

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
Peginterferon Alfa-2a Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.

Participant Flow:   Overall Study
    Peginterferon Alfa-2a  
STARTED     141  
COMPLETED     84  
NOT COMPLETED     57  
Premature Study Termination                 26  
Failure to Return                 10  
Moved to Another Center                 3  
Lost to Follow-up                 3  
Refused Treatment/Withdrew Consent                 1  
Insufficient Therapeutic Response                 4  
Adverse Event                 1  
Protocol Deviation                 2  
Principal Investigator Decision                 1  
Reason Not Specified                 2  
Missing Information                 4  



  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.
Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.

Reporting Groups
  Description
Peginterferon Alfa-2a Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.

Baseline Measures
    Peginterferon Alfa-2a  
Number of Participants  
[units: participants]
  139  
Age  
[units: years]
Mean (Standard Deviation)
  40.10  (10.45)  
Gender  
[units: participants]
 
Female     20  
Male     119  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study   [ Time Frame: At the end of the study (Week 36) ]

2.  Secondary:   Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment   [ Time Frame: At the end of treatment (Week 24) ]

3.  Primary:   Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Safety: Incidence of Adverse Events   [ Time Frame: approximately 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667432     History of Changes
Other Study ID Numbers: ML25626
Study First Received: August 15, 2012
Results First Received: October 1, 2015
Last Updated: November 3, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency