Study of Telbivudine in Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00970216
First received: September 1, 2009
Last updated: January 31, 2016
Last verified: January 2016
Results First Received: January 31, 2016  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Chronic Hepatitis B
Intervention: Drug: Telbivudine

  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
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
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
  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.
No text entered.

Reporting Groups
  Description
Chronic Hepatitis B Patients with chronic hepatitis B, who received Telbivudine treatment

Baseline Measures
    Chronic Hepatitis B  
Number of Participants  
[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
  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 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
Study First Received: September 1, 2009
Results First Received: January 31, 2016
Last Updated: January 31, 2016
Health Authority: China: Ministry of Health