Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus

April 11, 2006 updated by: Bukwang Pharmaceutical

A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus

The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Guro-ku, Seoul
      • Guro-dong, Guro-ku, Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
    • Jongno-Gu, Seoul
      • Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of, 110-744
        • Seoul National University
    • Kangdong-Gu, Seoul
      • Gil-dong, Kangdong-Gu, Seoul, Korea, Republic of, 134-701
        • Kangdong Sacred Heart Hospital
    • Kangnam-Gu, Seoul
      • Dogok-dong, Kangnam-Gu, Seoul, Korea, Republic of, 146-92
        • Yongdong Severance Hospital
      • Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
    • Songpa-Gu, Seoul
      • Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of, 388-1
        • Asan Medical Center
    • Yangchon-Gu, Seoul
      • Mok-dong, Yangchon-Gu, Seoul, Korea, Republic of, 911-1
        • Ewha Womans University Hospital
    • Yougdungpo-Gu, Seoul
      • Youido, Yougdungpo-Gu, Seoul, Korea, Republic of, 150-713
        • St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient who is between 18 and 60 years of age, inclusive
  2. Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.

  3. Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.

    Evidence of HBsAg (+) for the previous 6 months may include the following:

    • documentation of HBsAg (+) for the previous 6 months
    • documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
    • IgM anti-HBc negative and IgG anti-HBc positive at screening
  4. Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
  5. Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
  6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

  7. Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:

    • have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
    • continue with period 1 log10 decrease in HBV DNA from baseline.

Exclusion Criteria:

  1. Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
  3. Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
  4. Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
  6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
  7. Patient who is pregnant or breast-feeding.
  8. Patient who is unwilling to use an "effective" method of contraception during the study and for up to 30 days after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., intrauterine device [IUD], barrier methods with spermicide or abstinence)
  9. Patient who has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Patient who has creatinine clearance less than 60 mL/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]

Patients found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy: Change from baseline in HBV DNA (log10)

Secondary Outcome Measures

Outcome Measure
Safety
Vital Signs
Adverse Events
Laboratory tests
Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
Proportion of patients with hepatitis Be antigen (HBeAg) loss
Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
Biochemical improvement (e.g., ALT normalization)
Electrocardiogram (ECG)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 19, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Estimate)

April 12, 2006

Last Update Submitted That Met QC Criteria

April 11, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-FMAU-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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