A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00962871
First received: August 19, 2009
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: December 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic
Interventions: Drug: peginterferon alfa-2a [Pegasys]
Drug: tenofovir

  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 between 30 July 2009 to 01 February 2012 and recruited participants from 4 centers in New Zealand (1), Taiwan (1), and Singapore (2).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 65 participants were screened of which 30 participants were randomized. 35 participants failed the screening evaluation mainly due to inability to meet the inclusion criteria and consent withdrawal.

Reporting Groups
  Description
Tenofovir 300 mg Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
PEG-IFN Alfa-2a 360 μg Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
Delayed Treatment Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.

Participant Flow:   Overall Study
    Tenofovir 300 mg     Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg     PEG-IFN Alfa-2a 360 μg     Delayed Treatment  
STARTED     6     6     12     6  
COMPLETED     6     6     12     6  
NOT COMPLETED     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Tenofovir 300 mg Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
PEG-IFN Alfa-2a 360 μg Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
Delayed Treatment Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
Total Total of all reporting groups

Baseline Measures
    Tenofovir 300 mg     Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg     PEG-IFN Alfa-2a 360 μg     Delayed Treatment     Total  
Number of Participants  
[units: participants]
  6     6     12     6     30  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     6     12     6     30  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  37.8  (11.09)     28  (3.16)     28.5  (5.40)     27.2  (3.87)     30  (7.26)  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     6     6     12     6     30  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Viral Quantitative e Antibody   [ Time Frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys) ]

2.  Secondary:   Mean Change From Baseline in HBV-DNA log10   [ Time Frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys) ]

3.  Secondary:   Early Changes in Viral Sequence Associated With Viral Suppression   [ Time Frame: Day 1, 5, 14, Week 4 and 6 ]
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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
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: NCT00962871     History of Changes
Other Study ID Numbers: PP22512
Study First Received: August 19, 2009
Results First Received: December 9, 2015
Last Updated: January 14, 2016
Health Authority: New Zealand: Health Research Council