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

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.

Study Overview

• Status: Completed
• Conditions: HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
• Intervention / Treatment: Drug: Clevudine; Drug: Adefovir dipivoxil

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with HBV DNA below 300copies/mL	at week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 5, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Adefovir; Adefovir dipivoxil; Clevudine
• Other Study ID Numbers: CLV-401