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A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

This study has been completed.
Information provided by:
Bukwang Pharmaceutical Identifier:
First received: May 2, 2008
Last updated: December 17, 2014
Last verified: July 2012
The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.

Condition Intervention Phase
Patients With LC-B Drug: Clevudine Drug: Adefovir dipivoxil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B

Resource links provided by NLM:

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR

Secondary Outcome Measures:
  • The change of HBV DNA from the baseline.
  • Child-Pugh score improvement
  • MELD score improvement
  • Biochemical improvement
  • Proportion of patients with HBeAg loss and/or seroconversion

Estimated Enrollment: 102
Study Start Date: December 2007
Study Completion Date: September 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Clevudine
Other Name: Levovir
Active Comparator: 2
Drug: Adefovir dipivoxil
Other Name: Hepsera


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is 18 years and older.
  2. 5 ≦ Child-Pugh score ≦ 12
  3. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
  4. Patient is documented to be HBsAg positive for > 6 months.
  5. Patient is HBeAg positive or negative.
  6. Patient has ALT or AST levels which are in the range of > 1 x ULN and < 15 X ULN
  7. Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
  8. Life expectancy of at least 12 months
  9. Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
  10. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  2. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  3. Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient with clinical evidence of hepatocellular carcinoma
  6. Patient has alpha-fetoprotein > 400ng/mL.
  7. Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm3.
  8. Patient is pregnant or breast-feeding.
  9. 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.
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. Patient with previous liver transplantation
  12. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
  13. 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]
  Contacts and Locations
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Please refer to this study by its identifier: NCT00672867

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information Identifier: NCT00672867     History of Changes
Other Study ID Numbers: L-FMAU-309
Study First Received: May 2, 2008
Last Updated: December 17, 2014

Additional relevant MeSH terms:
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents processed this record on June 26, 2017