A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

NCT ID: NCT00641082

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

Brief Summary

A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.

Conditions

HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Clevudine

Group Type: EXPERIMENTAL

Clevudine

Intervention Type: DRUG

30mg for 48 weeks

2

Adefovir

Group Type: ACTIVE_COMPARATOR

Adefovir dipivoxil

Intervention Type: DRUG

10mg for 48 weeks

Interventions

Clevudine

30mg for 48 weeks

Intervention Type: DRUG

Adefovir dipivoxil

10mg for 48 weeks

Intervention Type: DRUG

Other Intervention Names

Levovir; Hepsera

Eligibility Criteria

Inclusion Criteria

• Patient is between 18 and 60
• Patient is documented to be HBsAg positive for > 6 months.
• Patient with compensated hepatic function.
• Nucleoside treatment-naÃ-ve subjects of either gender
• Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
• Patient has ALT levels which are in the range of 2 x ULN and < 10 X ULN
• Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.

Exclusion Criteria

• Patient is currently receiving antiviral or corticosteroid therapy.
• Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, 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.
• Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
• 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.
• Patient is coinfected with HCV, HDV or HIV.
• Patient with following clinical evidence

• Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
• Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
• Previous organ transplantation
• Patient has a clinically relevant history of abuse of alcohol or drugs.
• 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 α-Fetoprotein more than 100ng/mL
• Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/mm3
• 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

Locations

Seoul National University Bundang Hospital

Bundang, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CLV-401

Identifier Type: -

Identifier Source: org_study_id