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Study of Telbivudine in Chronic Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970216
First Posted: September 2, 2009
Last Update Posted: February 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
Results First Submitted: January 31, 2016  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Chronic Hepatitis B
Intervention: 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
Chronic Hepatitis B Patients with chronic hepatitis B, who received Telbivudine treatment

Participant Flow:   Overall Study
    Chronic Hepatitis B
STARTED   160 
COMPLETED   80 
NOT COMPLETED   80 



  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 with chronic hepatitis B, who received Telbivudine treatment

Baseline Measures
   Chronic Hepatitis B 
Overall Participants Analyzed 
[Units: Participants]
 160 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   150 
>=65 years   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.9  (10.1) 
Gender 
[Units: Participants]
 
Female   29 
Male   131 
Region of Enrollment 
[Units: Participants]
 
Taiwan   160 


  Outcome Measures

1.  Primary:   HBV-DNA < 300 Copies/mL in 48 Weeks   [ Time Frame: 48 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Chau-Ting Yeh
Organization: Chang Gung Memorial Hospital
phone: 88633281200 ext 8121
e-mail: chautingy@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00970216     History of Changes
Other Study ID Numbers: PMST-Y-1
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: January 31, 2016
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016