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

September 1, 2009
July 10, 2011
February 2009
January 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00970216 on ClinicalTrials.gov Archive Site
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Study of Telbivudine in Chronic Hepatitis B
A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

Chronic Hepatitis B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Hsiang-min Kung +886-3-3281200 ext 2224 hsiang0721@gmail.com
Taiwan
 
NCT00970216
PMST-Y-1
Yes
Chau-ting, Yeh, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Chau-ting Yeh, MD,PhD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP