Status:
TERMINATED
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
Eligibility Criteria
Inclusion
- Patients who were between 18 and 60, inclusive
- Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for \> 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg negative and HBeAb positive.
- Patients with ALT levels which were in the range of ≥1.2 and \< 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
- Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients coinfected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alfa-fetoprotein \> 50 ng/mL
- Patients who were pregnant or breast-feeding.
- Patients who were unwilling to use an "effective" method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
- Patients with a clinically relevant history of abuse of alcohol or drugs.
- Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
- Patients with creatinine clearance less than 60mL/min as estimated by the following formula:
- (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00313274
Start Date
July 1 2003
End Date
December 1 2004
Last Update
February 1 2017
Active Locations (30)
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1
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
2
Pusan Paik Hospital
Gaegeum-dong, Busan, South Korea
3
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu, Seoul, South Korea
4
Keimyumg University Dongsan Medical Center
Jung-gu, Daegu, South Korea