Long-term Study With Clevudine

Bukwang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: Clevudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00558818

KOR-404

Details and patient eligibility

About

A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.
Patient is documented to be HBsAg positive for > 6 months.
Patient has ALT levels >=80 IU/L
Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon within the previous 6 months.
Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine 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 decompensated liver disease or hepatocellular carcinoma
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.
Patient has a clinically relevant history of abuse of alcohol or drugs.
Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
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]