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

Phase 4

Completed

• Conditions: HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
• Interventions: Drug: Clevudine; Drug: Adefovir dipivoxil

• Registration Number: NCT00641082
• Lead Sponsor: Bukwang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-21
• Primary Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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]

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clevudine	Clevudine
2	Adefovir dipivoxil	Adefovir

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBV DNA below 300copies/mL	at week 48

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Bundang, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of