Study of Telbivudine in Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970216
• Other study ID #: PMST-Y-1
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: January 31, 2016
• Start date: February 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Telbivudine
Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	LinKou, Taoyuan County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV-DNA < 300 Copies/mL in 48 Weeks		48 weeks	No