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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

This study has been completed.
Information provided by:
Bukwang Pharmaceutical Identifier:
First received: March 5, 2008
Last updated: April 24, 2012
Last verified: April 2012
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 Intervention Phase
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Drug: Clevudine
Drug: Adefovir dipivoxil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA below 300copies/mL [ Time Frame: at week 48 ]

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

Enrollment: 43
Study Start Date: February 2008
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Clevudine
30mg for 48 weeks
Other Name: Levovir
Active Comparator: 2
Drug: Adefovir dipivoxil
10mg for 48 weeks
Other Name: Hepsera


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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]
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Please refer to this study by its identifier: NCT00641082

Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information Identifier: NCT00641082     History of Changes
Other Study ID Numbers: CLV-401
Study First Received: March 5, 2008
Last Updated: April 24, 2012

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Adefovir dipivoxil
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents processed this record on May 25, 2017