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Study of Telbivudine in Chronic Hepatitis B

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00970216
First received: September 1, 2009
Last updated: July 10, 2011
Last verified: March 2010
History of Changes
  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
Chronic Hepatitis B

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:

Drug Information available for: Telbivudine
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Biospecimen Retention:   Samples With DNA

Serum will be stored at screening/baseline and complete study after corresponding with inclusion/exclusion criteria.


Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970216

Contacts
Contact: Hsiang-min Kung +886-3-3281200 ext 2224 hsiang0721@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
LinKou, Taoyuan County, Taiwan
Contact: Hsiang-min Kung     +886-3-3281200 ext 2224     hsiang0721@gmail.com    
Principal Investigator: Chau-ting Yeh, MD, PhD            
Sub-Investigator: Chao-Wei Hsu, MD            
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chau-ting Yeh, MD,PhD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chau-ting, Yeh, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00970216     History of Changes
Other Study ID Numbers: PMST-Y-1
Study First Received: September 1, 2009
Last Updated: July 10, 2011
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
 Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on June 17, 2013