A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01706575
First received: October 10, 2012
Last updated: June 24, 2016
Last verified: June 2016
Results First Received: June 24, 2016  
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
Interventions: Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Drug: Nucleos(t)ide Analogues (NA)

  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
A total of 76 participants started the study and were included in lead-in period. Out of 76 participants, 70 received study drug. Data is reported here for the interim analysis (48 weeks).

Reporting Groups
  Description
Pegylated Interferon (Peginterferon) Alfa-2a Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.

Participant Flow:   Overall Study
    Pegylated Interferon (Peginterferon) Alfa-2a  
STARTED     76  
COMPLETED     46  
NOT COMPLETED     30  
No HBsAg Decrease at Week 24                 11  
Adverse Event                 8  
Participant Withdrew Consent                 2  
Lack of Compliance                 1  
Reason not Specified                 2  
Started but not Treated                 6  



  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.
Lead-in participants included all participants enrolled in lead-in period.

Reporting Groups
  Description
Pegylated Interferon (Peginterferon) Alfa-2a Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.

Baseline Measures
    Pegylated Interferon (Peginterferon) Alfa-2a  
Number of Participants  
[units: participants]
  76  
Age  
[units: years]
Mean (Standard Deviation)
  30.98  (12.33)  
Gender  
[units: participants]
 
Female     13  
Male     63  



  Outcome Measures
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1.  Primary:   Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)   [ Time Frame: Baseline up to Week 48 ]

2.  Primary:   Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)   [ Time Frame: Baseline and Week 48 ]

3.  Secondary:   Safety: Number of Participants With Adverse Events (AE)   [ Time Frame: Baseline up to Week 48 ]

4.  Secondary:   Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96   [ Time Frame: Baseline, Week 24, 72 and 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48   [ Time Frame: Baseline and Week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Efficacy: Percentage of Participants With Serum HBsAg Loss at Week 48, 72 and 96   [ Time Frame: Week 48, 72 and 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes   [ Time Frame: Baseline and Week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels   [ Time Frame: Baseline and Week 48 ]
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
Results for some secondary outcome measure was not reported as they were not the part of interim analysis. Results will be updated with final data once available.


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01706575     History of Changes
Other Study ID Numbers: ML28262
2012-000080-25 ( EudraCT Number )
Study First Received: October 10, 2012
Results First Received: June 24, 2016
Last Updated: June 24, 2016
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)