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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
  Purpose
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or 60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.

Condition Intervention
Chronic Hepatitis B
Drug: Telbivudine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • HBV-DNA < 300 Copies/mL in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Serum will be stored at screening/baseline and complete study after corresponding with inclusion/exclusion criteria.

Enrollment: 160
Study Start Date: February 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Telbivudine
    Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment
    Other Name: Sebivo
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age.
  2. Documented chronic hepatitis B defined by all of the following:

    • Clinical history compatible with chronic hepatitis B.
    • Detectable serum hepatitis B surface antigen >= 6 months at screening visit, with either HBeAg positive or negative.
  3. Willing and able to comply with the observational drug regimen and all other study requirements.
  4. Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Females who are pregnant,intending to become pregnant or breast feeding.
  2. Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
  3. Patients with hypersensitivity to telbivudine or to any of the excipients.
  4. One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
  5. Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
  6. Unable to receive safety and tolerability assessments.
  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: NCT00970216

Locations
Taiwan
Chang Gung Memorial Hospital
LinKou, Taoyuan County, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chau-ting Yeh, MD,PhD Chang Gung Memorial Hospital
  More Information

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
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
HBV DNA non-detectability

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on September 26, 2016