Status:
TERMINATED
Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Hepatitis B
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
Eligibility Criteria
Inclusion
- Patient is between 18 and 60, inclusive
- Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
- Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
- Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
- Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
- Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
- 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) or post-menopausal or using at least 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, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
- (140-age in years) (body weight \[kg\])/(72)(serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
- Patient whom investigator consider is not suitable in this study
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00362505
Start Date
June 1 2004
End Date
March 1 2006
Last Update
February 1 2017
Active Locations (32)
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1
Pusan National University Hospital
Ami-dong, Seo-gu, Busan, South Korea
2
Kosin Medical Center
Amnam-dong, Seo-gu, Busan, South Korea
3
Pusan Paik Hospital
Gaegeum-dong, Busan, South Korea
4
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daechon, South Korea