N/A
N=160
Study of Telbivudine in Chronic Hepatitis B
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00970216 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: HBV-DNA < 300 Copies/mL in 48 Weeks — 79 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Telbivudine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HBV-DNA < 300 Copies/mL in 48 Weeks |
79 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female, at least 18 years of age.
- 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.
- Willing and able to comply with the observational drug regimen and all other study requirements.
- Willing and able to provide written informed consent to participate in the study.
Exclusion Criteria
- Females who are pregnant, intending to become pregnant or breast feeding.
- Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
- Patients with hypersensitivity to telbivudine or to any of the excipients.
- 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.
- Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
- Unable to receive safety and tolerability assessments.
Data sourced from ClinicalTrials.gov (NCT00970216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.