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Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01958229
First Posted: October 9, 2013
Last Update Posted: October 9, 2013
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):
National Taiwan University Hospital
  Purpose
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.

Condition
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 ]
  • HBeAg seroconversion rate [ Time Frame: week 52 ]
  • PCR negativity [ Time Frame: week 104 ]
  • HBeAg seroconversion rate [ Time Frame: week 104 ]

Secondary Outcome Measures:
  • Rate of ALT normalization [ Time Frame: week 52 ]
  • Genotypic resistance [ Time Frame: week 52 ]
  • Rate of ALT normalization [ Time Frame: week 104 ]
  • Genotypic resistance [ Time Frame: week 104 ]

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)
Groups/Cohorts
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.

Objectives:

Primary:

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.

Secondary:

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

Population:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic hepatitis B patients without cirrhosis
Criteria

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
Information from the National Library of Medicine

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): NCT01958229


Locations
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
First Submitted: October 1, 2013
First Posted: October 9, 2013
Last Update Posted: October 9, 2013
Last Verified: October 2013

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