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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519921
First received: January 5, 2012
Last updated: March 22, 2016
Last verified: March 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic
Intervention: Drug: peginterferon 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 150 participants were enrolled in this study conducted from 26 October 2005 to 24 June 2008 at 7 centers in Republic of Korea.

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
PEG-IFN Alfa-2a (Treatment naïve) Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
PEG-IFN Alfa-2a (YMDD Mutant) Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.

Participant Flow:   Overall Study
    PEG-IFN Alfa-2a (Treatment naïve)   PEG-IFN Alfa-2a (YMDD Mutant)
STARTED   86   64 
COMPLETED   65   49 
NOT COMPLETED   21   15 
Adverse Event                10                9 
Lack of Efficacy                4                3 
Withdrawal by Subject                3                0 
Lost to Follow-up                2                1 
Treatment refusal                2                1 
High alanine aminotransferase (ALT)                0                1 



  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.
Baseline characteristics were analysed on Intent-to-treat (ITT) population which included all participants who received at least one dose of study drug. The ITT and the safety populations were identical.

Reporting Groups
  Description
PEG-IFN Alfa-2a (Treatment naïve) Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
PEG-IFN Alfa-2a (YMDD Mutant) Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
Total Total of all reporting groups

Baseline Measures
    PEG-IFN Alfa-2a (Treatment naïve)   PEG-IFN Alfa-2a (YMDD Mutant)   Total
Overall Participants Analyzed 
[Units: Participants]
 86   64   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.3  (9.20)   36.8  (9.0)   35.9  (9.1) 
Gender 
[Units: Participants]
     
Female   23   10   33 
Male   63   54   117 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72   [ Time Frame: Week 72 ]

2.  Primary:   Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72   [ Time Frame: Week 72 ]

3.  Secondary:   Percentage of Participants With ALT Normalization At Week 48 and Week 72   [ Time Frame: Week 48 and Week 72 ]

4.  Secondary:   Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72   [ Time Frame: Week 48 and Week 72 ]

5.  Secondary:   Percentage of Participants With a Combined Response At Week 48 and Week 72   [ Time Frame: Week 48 and Week 72 ]

6.  Secondary:   Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion   [ Time Frame: Week 48 and Week 72 ]

7.  Secondary:   Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72   [ Time Frame: Week 48 and Week 72 ]

8.  Secondary:   Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72   [ Time Frame: Week 48 and Week 72 ]

9.  Secondary:   Number of Participants With Any Adverse Events and Any Serious Adverse Events   [ 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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519921     History of Changes
Other Study ID Numbers: ML18495
Study First Received: January 5, 2012
Results First Received: December 17, 2015
Last Updated: March 22, 2016
Health Authority: Korea: Korea Food and Drug Administration