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OpenTrials
Completed

NCT Number: NCT00672867

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  • Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  • Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient with clinical evidence of hepatocellular carcinoma
  • Patient has alpha-fetoprotein > 400ng/mL.
  • Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm3.
  • 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 a clinically relevant history of abuse of alcohol or drugs.
  • Patient with previous liver transplantation
  • 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.
  • 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]

Treatment and study plan

Clevudine

Drug

30mg

Other names: Levovir

Adefovir dipivoxil

Drug

10mg

Other names: Hepsera

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study title

A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
May 6, 2008
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.