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: December 17, 2015
Last verified: December 2015
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: 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
  Hide Participant Flow

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 at 7 centers in Korea from 26th October 2005 to 24th June 2008.

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
Group A Treatment naïve participants who received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Group B YMDD (tyrosine-methionine-aspartate-aspartate) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received Lamivudine (LAM) concomitantly for the initial 12 weeks.

Participant Flow:   Overall Study
    Group A     Group B  
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 ALT                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Group A Group A included treatment naïve participants who received PEGASYS 180 micrograms (mcg) subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Group B Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Total  
Number of Participants  
[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 (HBV-DNA) <100,000 Copies/mL   [ Time Frame: Week 72 ]

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

3.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) Normalization   [ Time Frame: Week 48 and Week 72 ]

4.  Secondary:   Percentage of Participants With HBV-DNA Below the Limit of Detection   [ Time Frame: Week 48 and Week 72 ]

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

6.  Secondary:   Percentage of Participants With HBeAg Seroconversion   [ Time Frame: Week 48 and Week 72 ]

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

8.  Secondary:   Percentage of Participants With HBsAg Seroconversion   [ Time Frame: Week 48 and Week 72 ]

9.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Up to Week 72 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


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: December 17, 2015
Health Authority: Korea: Korea Food and Drug Administration