Chronic Hepatitis B
Conditions
Keywords
HBV DNA non-detectability
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.
Interventions
DRUGTelbivudine
Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment
Sponsors
Chang Gung Memorial Hospital
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA < 300 Copies/mL in 48 Weeks | 48 weeks |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Hepatitis B Patients with chronic hepatitis B, who received Telbivudine treatment | 160 |
| Total | 160 |
Baseline characteristics
| Characteristic | Chronic Hepatitis B |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 52.9 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Taiwan | 160 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 160 |
| serious Total, serious adverse events | 0 / 160 |
Outcome results
Primary
HBV-DNA < 300 Copies/mL in 48 Weeks
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic Hepatitis B | HBV-DNA < 300 Copies/mL in 48 Weeks | 79 participants |