Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
Phase 3
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00362635
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- Patient is between 18 and 60, inclusive.
- Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
- Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
- Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
- Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
- Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
- Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is co-infected with HCV or HIV.
- Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
- Patient is pregnant or breast-feeding.
- Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence).
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
- Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR Safety: Laboratory tests, Adverse Events, Physical examination
- Secondary Outcome Measures
Name Time Method Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period Efficacy: Viral kinetics of HBV DNA suppression Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine. Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
Trial Locations
- Locations (2)
Queen Mary Hospital
ðŸ‡ðŸ‡°Road, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
ðŸ‡ðŸ‡°Tai Po, New Territories, Hong Kong