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

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00641082

Collaborator

(none)

Enrollment

Locations

Arms

21.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function	Drug: Clevudine Drug: Adefovir dipivoxil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Clevudine	Drug: Clevudine 30mg for 48 weeks Other Names: Levovir
Active Comparator: 2 Adefovir	Drug: Adefovir dipivoxil 10mg for 48 weeks Other Names: Hepsera

Arm

Intervention/Treatment

Experimental: 1

Clevudine

Drug: Clevudine

30mg for 48 weeks

Other Names:

Levovir

Active Comparator: 2

Adefovir

Drug: Adefovir dipivoxil

10mg for 48 weeks

Other Names:

Hepsera

Outcome Measures

Primary Outcome Measures

Proportion of patients with HBV DNA below 300copies/mL [at week 48]

Secondary Outcome Measures

The change of HBV DNA from the baseline [at week 24, 48]
Proportion of patients with HBV DNA below LOD of RT-PCR [at week 24, 48]
ALT normalization rate [at week 24, 48]
Proportion of patients with viral breakthrough during 48-week treatment period [at week 24, 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 â‰¥ 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 Î±-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]