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A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00436163
First received: February 15, 2007
Last updated: August 31, 2016
Last verified: August 2016
Results First Received: August 31, 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
Intervention: Drug: Peginterferon alfa-2a

  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
No text entered.

Reporting Groups
  Description
Peginterferon Alfa-2a Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.

Participant Flow:   Overall Study
    Peginterferon Alfa-2a
STARTED   39 
COMPLETED   36 
NOT COMPLETED   3 
Lost to Follow-up                2 
Adverse Event                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.
All enrolled participants who received at least 1 dose of peginterferon alfa-2a.

Reporting Groups
  Description
Peginterferon Alfa-2a Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.

Baseline Measures
   Peginterferon Alfa-2a 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.28  (13.141) 
Gender 
[Units: Participants]
 
Female   7 
Male   32 


  Outcome Measures
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1.  Primary:   Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)   [ Time Frame: Week 72 ]

2.  Primary:   Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL   [ Time Frame: Week 72 ]

3.  Secondary:   Number of Participants With HBV-DNA < 400 Copies/mL   [ Time Frame: Week 72 ]

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

5.  Secondary:   Percentage of Anti-HBs Positive Participants   [ Time Frame: Week 48 and Week 72 ]

6.  Secondary:   Mean Alanine Aminotransferase (ALT) Concentrations   [ Time Frame: Week 48 and Week 72 ]

7.  Secondary:   Percentage of HBeAg Negative Participants   [ Time Frame: Week 48 and Week 72 ]

8.  Secondary:   Percentage of Anti-HBe Positive Participants   [ Time Frame: Week 48 and Week 72 ]


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00436163     History of Changes
Other Study ID Numbers: ML20601
Study First Received: February 15, 2007
Results First Received: August 31, 2016
Last Updated: August 31, 2016
Health Authority: Estonia: State Agency of Medicines of the Republic of Estonia
Latvia: State Agency of Medicines of the Republic of Latvia
Lithuania: State Medicines Control Agency of Lithuania