Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

This study has been terminated.
(This study was terminated early due to poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01641926
First received: July 11, 2012
Last updated: March 10, 2017
Last verified: March 2017
Results First Received: November 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic
Interventions: Biological: PEG-Intron™
Biological: 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
Hepatitis B envelope antigen (HBeAg)-positive or -negative participants who were interferon treatment-naïve were recruited from 81 sites to be randomly assigned to receive pegylated inferferon alfa-2b (PEG-Intron™) or pegylated interferon alfa-2a (PEGASYS™).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
402 participants were enrolled and 399 participants were treated on study.

Reporting Groups
  Description
HBeAg(+) PEG-Intron HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
HBeAg(+) PEGASYS HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
HBeAg(-) PEG-Intron HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
HBeAg(-) PEGASYS HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.

Participant Flow:   Overall Study
    HBeAg(+) PEG-Intron   HBeAg(+) PEGASYS   HBeAg(-) PEG-Intron   HBeAg(-) PEGASYS
STARTED   143   145   57   57 
Treated (All Participants as Treated)   142   144   56   57 
COMPLETED   115   130   46   53 
NOT COMPLETED   28   15   11   4 
Adverse Event                5                2                3                1 
Lost to Follow-up                2                2                1                0 
Physician Decision                6                5                0                1 
Protocol Violation                1                0                0                1 
Withdrawal by Subject                13                5                6                1 
Not Treated                1                1                1                0 



  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.
All Participants as Treated (APaT: all randomized participants who received ≥1 dose of study medication

Reporting Groups
  Description
HBeAg(+) PEG-Intron HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
HBeAg(+) PEGASYS HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
HBeAg(-) PEG-Intron HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
HBeAg(-) PEGASYS HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
Total Total of all reporting groups

Baseline Measures
   HBeAg(+) PEG-Intron   HBeAg(+) PEGASYS   HBeAg(-) PEG-Intron   HBeAg(-) PEGASYS   Total 
Overall Participants Analyzed 
[Units: Participants]
 142   144   56   57   399 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (7.73)   33.6  (9.23)   41.1  (10.77)   42.0  (10.50)   35.5  (9.91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      54  38.0%      43  29.9%      21  37.5%      15  26.3%      133  33.3% 
Male      88  62.0%      101  70.1%      35  62.5%      42  73.7%      266  66.7% 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   142   144   56   57   399 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment   [ Time Frame: FU Week 24 (Study Week 72) ]

2.  Primary:   Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment   [ Time Frame: FU Week 24 (Study Week 72) ]

3.  Secondary:   Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment   [ Time Frame: FU Week 24 (Study Week 72) ]

4.  Secondary:   Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment   [ Time Frame: FU Week 24 (Study Week 72) ]

5.  Secondary:   Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment   [ Time Frame: FU Week 24 (Study 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01641926     History of Changes
Other Study ID Numbers: P08450
MK-4031-376 ( Other Identifier: Merck study number )
Study First Received: July 11, 2012
Results First Received: November 16, 2016
Last Updated: March 10, 2017