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OpenTrials
Completed

NCT Number: NCT01264354

An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.

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Key information

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.
  • Patient is documented to be HBsAg positive for > 6 months.
  • Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline.
  • Patient has ALT levels ≥ 1×ULN
  • 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.
  • Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
  • Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
  • Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  • Patient with clinical evidence of hepatocellular carcinoma
  • Patient with previous liver transplantation
  • Patient is pregnant or breast-feeding.
  • Patient has a clinically relevant history of abuse of alcohol or drugs.
  • 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 30mg

Drug

Clevudine 30mg

Other names: Levovir 30mg

Clevudine 20mg+Adefovir dipivoxil 10mg

Drug

Clevudine 20mg+ Adefovir 10mg

Other names: Levovir 20mg+Adefovir 10mg

Clevudine 20mg

Drug

Clevudine 20mg

Other names: Levovir 20mg

Primary outcomes

  1. Proportion of patients with HBV DNA levels < 300 copies/mL

    Time frame: 24 week

Secondary outcomes

  1. The change of HBV DNA form the baseline

    Time frame: 24week, 48week, 96week

    (log copies/mL)

  2. Proportion of patients with HBV DNA < 300 copies/mL

    Time frame: 48week, 96week

  3. Proportion of patients with ALT normalization

    Time frame: 24week, 48week, 96week

  4. Proportion of patients with HBeAg loss and/or seroconversion

    Time frame: 96 Week

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 21, 2010
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.

Published trials that share one or more normalized conditions with this study.