Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This study has been completed.
Sponsor:
Collaborator:
Idenix Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00412529
First received: December 15, 2006
Last updated: July 18, 2011
Last verified: July 2011
Results First Received: December 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis B
Chronic Hepatitis B
Interventions: Drug: Entecavir
Drug: Telbivudine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Telbivudine Telbivudine 600 mg once daily for 12 weeks.
Entecavir Entecavir 0.5 mg once daily for 12 weeks.

Participant Flow:   Overall Study
    Telbivudine     Entecavir  
STARTED     23     21  
COMPLETED     23     21  
NOT COMPLETED     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.
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Reporting Groups
  Description
Telbivudine Telbivudine 600 mg once daily for 12 weeks.
Entecavir Entecavir 0.5 mg once daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Telbivudine     Entecavir     Total  
Number of Participants  
[units: participants]
  23     21     44  
Age [1]
[units: Years]
Mean ± Standard Deviation
  36.2  ± 9.62     33.4  ± 8.82     34.9  ± 9.25  
Gender  
[units: Participants]
     
Female     5     9     14  
Male     18     12     30  
[1] Baseline Measures based on Intention to treat population.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean Hepatitis B Virus (HBV) DNA Levels   [ Time Frame: Baseline (day 1) to Week 12 (day 85) ]

2.  Secondary:   Change in Mean HBV DNA Level   [ Time Frame: Baseline (day 1) to Weeks 2, 4, 8 ]

3.  Secondary:   The Area Under the Curve (AUC) of HBV DNA Change.   [ Time Frame: From Baseline to Week 12 ]

4.  Secondary:   Change in Alanine Aminotransferase (ALT) Levels   [ Time Frame: From Baseline to Week 12 ]

5.  Secondary:   Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance   [ Time Frame: Baseline to 12 weeks ]

6.  Secondary:   Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss   [ Time Frame: Baseline to 12 weeks ]

7.  Secondary:   Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production   [ Time Frame: Baseline to 12 weeks ]

8.  Secondary:   Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative   [ Time Frame: At Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


Publications of Results:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00412529     History of Changes
Other Study ID Numbers: CLDT600A2407
Study First Received: December 15, 2006
Results First Received: December 2, 2010
Last Updated: July 18, 2011
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration