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Long-term Study With Clevudine

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: NCT00558818
Recruitment Status : Completed
First Posted : November 15, 2007
Last Update Posted : July 26, 2012
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Clevudine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus
Study Start Date : June 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Clevudine
    clevudine 30 mg qd

Primary Outcome Measures :
  1. Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR [ Time Frame: Screening, day1,every 12 weeks during treatment period(96weeks) ]

Secondary Outcome Measures :
  1. Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation [ Time Frame: Screening, day1, every 12 weeks during treatment period(96 weeks) ]

Information from the National Library of Medicine

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

Inclusion Criteria

  • Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.
  • Patient is documented to be HBsAg positive for > 6 months.
  • Patient has ALT levels >=80 IU/L
  • Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

  • Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  • Patients previously treated with interferon within the previous 6 months.
  • Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
  • Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
  • 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 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]

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): NCT00558818

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Korea, Republic of
KoreaUniversity Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
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Responsible Party: hunjun jang, Bukwang Pharmaceutical Identifier: NCT00558818    
Other Study ID Numbers: KOR-404
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents