A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697501
First received: September 28, 2012
Last updated: December 1, 2015
Last verified: October 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Hepatitis B, Chronic
Intervention: Other: Interleukin 28B testing

  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
Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.

Reporting Groups
  Description
Chronic Hepatitis B Patients Interleukin 28B testing: Blood sampling for IL28B genotyping

Participant Flow:   Overall Study
    Chronic Hepatitis B Patients  
STARTED     88  
COMPLETED     86  
NOT COMPLETED     2  
Protocol Violation                 2  



  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.
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Reporting Groups
  Description
Chronic Hepatitis B Patients Interleukin 28B testing: Blood sampling for IL28B genotyping

Baseline Measures
    Chronic Hepatitis B Patients  
Number of Participants  
[units: participants]
  86  
Age  
[units: years]
Mean (Standard Deviation)
  45.7  (9.6)  
Gender  
[units: participants]
 
Female     21  
Male     65  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)   [ Time Frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment. ]

2.  Primary:   Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF   [ Time Frame: EoF ]

3.  Secondary:   Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)   [ Time Frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96 ]

4.  Secondary:   Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT   [ Time Frame: EoT ]

5.  Secondary:   Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF   [ Time Frame: EoT and EoF ]

6.  Secondary:   Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF   [ Time Frame: EoT and EoF ]

7.  Secondary:   Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF   [ Time Frame: EoT and EoF ]

8.  Secondary:   Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF   [ Time Frame: EoT and EoF ]


  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: 1-800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697501     History of Changes
Other Study ID Numbers: ML28470
2012-002777-56 ( EudraCT Number )
Study First Received: September 28, 2012
Results First Received: June 10, 2015
Last Updated: December 1, 2015
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)