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A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects 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:
NCT00927082
First received: June 16, 2009
Last updated: February 10, 2016
Last verified: February 2016
Results First Received: February 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
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
The study was conducted from 10 April 2009 to 05 November 2014. A total of 383 participants were recruited from 31 centers across 9 countries (Australia, New Zealand, China, Taiwan, Singapore, Korea, Thailand, Brazil, and Russia).

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
PEG-IFN 90mcg 24 Wks Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
PEG-IFN 180mcg 24 Wks Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 90mcg 48 Wks Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 180mcg 48 Wks Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Participant Flow:   Overall Study
    PEG-IFN 90mcg 24 Wks     PEG-IFN 180mcg 24 Wks     PEG-IFN 90mcg 48 Wks     PEG-IFN 180mcg 48 Wks  
STARTED     91     87     108     97  
COMPLETED     79     77     86     78  
NOT COMPLETED     12     10     22     19  
Lost to Follow-up                 9                 8                 12                 16  
Withdrawal by Subject                 3                 2                 7                 2  
Death                 0                 0                 1                 0  
Screen fail,Participant migrated,Unknown                 0                 0                 2                 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.
The Intent-to-Treat analysis population included all participants who had received at least one dose of study medication in study WV19432 and provided informed consent for study MV22430. Participants were analyzed according to the treatment groups to which they had been randomized.

Reporting Groups
  Description
PEG-IFN 90mcg 24 Wks Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 180mcg 24 Wks Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 90mcg 48 Wks Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 180mcg 48 Wks Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Total Total of all reporting groups

Baseline Measures
    PEG-IFN 90mcg 24 Wks     PEG-IFN 180mcg 24 Wks     PEG-IFN 90mcg 48 Wks     PEG-IFN 180mcg 48 Wks     Total  
Number of Participants  
[units: participants]
  91     87     108     97     383  
Age  
[units: years]
Mean (Standard Deviation)
  32.5  (9.73)     34.5  (10.54)     34.3  (10.82)     34.2  (10.78)     33.9  (10.49)  
Gender  
[units: participants]
         
Female     34     23     33     35     125  
Male     57     64     75     62     258  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.   [ Time Frame: Annually, for up to 5 years ]

2.  Primary:   Percentage of Participants With HBsAg Loss   [ Time Frame: Annually, for up to 5 years ]

3.  Secondary:   Percentage of Participants With HBeAg Loss.   [ Time Frame: Annually, for up to 5 years ]

4.  Secondary:   Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.   [ Time Frame: Annually, for up to 5 years ]

5.  Secondary:   Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).   [ Time Frame: Annually, for up to 5 years ]

6.  Secondary:   Percentage of Participants With Presence of Anti-HBs   [ Time Frame: Annually, for up to 5 years ]

7.  Secondary:   Percentage of Participants With Normalised Alanine Transaminase (ALT)   [ Time Frame: Annually, for up to 5 years ]

8.  Secondary:   Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).   [ Time Frame: Annually, for up to 5 years ]

9.  Secondary:   Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)   [ Time Frame: Annually, for up to 5 years ]

10.  Secondary:   Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)   [ Time Frame: Annually, for up to 5 years ]

11.  Secondary:   Quantitative HBsAg   [ Time Frame: Annually, for up to 5 years ]

12.  Secondary:   Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B   [ Time Frame: Up to 5-year FU period ]

13.  Secondary:   Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)   [ Time Frame: Up to 5-year FU period ]

14.  Secondary:   Number of Participants With Marked Laboratory Abnormalities   [ Time Frame: Up to 5-year FU period ]


  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

Of the responders at FU Year 5, the proportion of patients who were receiving additional anti-HBV treatment after FU Week 24 varied between groups.

The frequency of missing values (counted as non-response) was unevenly distributed between groups.



  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: NCT00927082     History of Changes
Other Study ID Numbers: MV22430
Study First Received: June 16, 2009
Results First Received: February 10, 2016
Last Updated: February 10, 2016
Health Authority: Australia: National Health and Medical Research Council