Long-term Study With Clevudine

NCT ID: NCT00558818

Last Updated: 2012-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Clevudine

clevudine 30 mg qd

Intervention Type: DRUG

Eligibility 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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Bukwang Pharmaceutical

Locations

KoreaUniversity Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KOR-404

Identifier Type: -

Identifier Source: secondary_id

KOR-404

Identifier Type: -

Identifier Source: org_study_id