Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

This study has been completed.
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
First received: October 1, 2013
Last updated: October 8, 2013
Last verified: October 2013
This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.

Chronic Hepatitis B
Roadmap Concept in Chronic Hepatitis B Treatment
24-week PCR Negativity of Telbivudine
PCR Negativity at 52 and 104 Week
HBeAg Seroconversion Rate at 52 and 104 Week

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • PCR negativity [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • HBeAg seroconversion rate [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • PCR negativity [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • HBeAg seroconversion rate [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of ALT normalization [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Genotypic resistance [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Rate of ALT normalization [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • Genotypic resistance [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
10 c.c whole blood

Enrollment: 23
Study Start Date: December 2009
Study Completion Date: April 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
CHB patients without cirrhosis

Detailed Description:

This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.

Study purpose:

This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.



To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.


  1. To observe the treatment outcomes.
  2. To validate the result of super-responder trial.
  3. To validate the Roadmap Concept.


The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic hepatitis B patients without cirrhosis

Inclusion Criteria:

  • Male or female 18 to 65 years of age
  • Documented chronic hepatitis B defined by ALL of following:

    1. Clinical history compatible with compensated chronic hepatitis B
    2. Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit.

Exclusion Criteria:

  • Pregnant or nursing
  • co-infection with hepatitis C virus (HCV) or HIV
  • Clinical or imaging diagnosis of cirrhosis
  • Evidence of decreased renal function of creatinine >(=)2x ULN
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958229

National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jia-Horng Kao, Professor National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01958229     History of Changes
Other Study ID Numbers: 200910027M 
Study First Received: October 1, 2013
Last Updated: October 8, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2016