Clinical trial NCT00970216: Study of Telbivudine in Chronic Hepatitis B
Official title: A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Keywords: HBV DNA non-detectability
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: HBV-DNA < 300 Copies/mL in 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: LinKou, Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chau-ting Yeh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin CL, Chien RN, Yeh C, Hsu CW, Chang ML, Chen YC, Yeh CT. Significant renoprotective effect of telbivudine during preemptive antiviral therapy in advanced liver cancer patients receiving cisplatin-based chemotherapy: a case-control study. Scand J Gastroenterol. 2014 Dec;49(12):1456-64. doi: 10.3109/00365521.2014.962604. Epub 2014 Oct 6.