This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Long-term Study With Clevudine

This study has been completed.
Information provided by:
Bukwang Pharmaceutical Identifier:
First received: November 14, 2007
Last updated: July 24, 2012
Last verified: July 2012
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 Intervention Phase
Chronic Hepatitis B Drug: Clevudine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • 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:
  • 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) ]

Estimated Enrollment: 150
Study Start Date: June 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Clevudine
    clevudine 30 mg qd

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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00558818

Korea, Republic of
KoreaUniversity Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

Responsible Party: hunjun jang, Bukwang Pharmaceutical Identifier: NCT00558818     History of Changes
Other Study ID Numbers: KOR-404
Study First Received: November 14, 2007
Last Updated: July 24, 2012

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017