Study of Telbivudine in Chronic Hepatitis B
|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.|
|ClinicalTrials.gov Identifier: NCT00970216|
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis B||Drug: Telbivudine|
Primary objective: To evaluate the antiviral efficacy of telbivudine by maintained suppression of HBV DNA(<=300 copies/ml or 60 IU/ml,undetectable by current PCR-based assays) in HBeAg positive patients from Week 24 to Week 48.
Methodology: This will be an open-label, prospective, observational, single-center and single arm post marketing surveillance study.
Number of patients: It is estimated to enroll 240 intent-to-treat patients in Taiwan.
Population: Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
- Drug: Telbivudine
Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatmentOther Name: Sebivo
- HBV-DNA < 300 Copies/mL in 48 Weeks [ Time Frame: 48 weeks ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970216
|Chang Gung Memorial Hospital|
|LinKou, Taoyuan County, Taiwan|
|Principal Investigator:||Chau-ting Yeh, MD,PhD||Chang Gung Memorial Hospital|