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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672867
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : December 18, 2014
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.

Condition or disease Intervention/treatment Phase
Patients With LC-B Drug: Clevudine Drug: Adefovir dipivoxil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Clevudine
Other Name: Levovir

Active Comparator: 2
Drug: Adefovir dipivoxil
Other Name: Hepsera

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672867

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical Identifier: NCT00672867     History of Changes
Other Study ID Numbers: L-FMAU-309
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: July 2012

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