Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV

January 30, 2017 updated by: Bukwang Pharmaceutical

A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 mg QD in Patients Chronically Infected With Hepatitis B Virus

The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 3

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
      • Incheon, Korea, Republic of
        • Gil Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
    • Bupyoung-gu, Incheon
      • Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
        • St. Mercy's Hospital
    • Chongro-gu, Seoul
      • Pyoung-dong, Chongro-gu, Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
    • Daegu
      • Jung-gu, Daegu, Korea, Republic of
        • Kyungpook National University Medical Hospital
      • Jung-gu, Daegu, Korea, Republic of
        • Keimyumg University Dongsan Medical Center
    • Dong-gu, Gwangju-si
      • Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republic of
        • Chonnam National University Hospital
    • Gro-gu
      • Seoul, Gro-gu, Korea, Republic of
        • Korea University Guro Hospital
    • Jeonbuk
      • Iksan-City, Jeonbuk, Korea, Republic of
        • Wonkwang University Hospital
      • Jeonju-city, Jeonbuk, Korea, Republic of
        • Chonbuk National University Hospital
    • Jung-gu, Daechon
      • Daesa-dong, Jung-gu, Daechon, Korea, Republic of
        • Chungnam National University Hospital
    • Jung-gu, Incheon
      • Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
        • Inha University Hospital
    • Kangnam-gu, Seoul
      • Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
        • Yongdong Severance Hospital
      • Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
        • Seoul ASAN Medical Center
    • Kyounggi-do
      • Ilsan-gu,, Kyounggi-do, Korea, Republic of
        • National Cancer Center
      • Pucheon, Kyounggi-do, Korea, Republic of
        • St. Holly Family Mary's Hospital
      • Seongnam-gu, Kyounggi-do, Korea, Republic of
        • Pochon CHA University Hospital
    • Nam-gu, Taegu
      • Dae myoung-dong, Nam-gu, Taegu, Korea, Republic of
        • Yeungnam University Medical Center
    • Nowon-gu, Seoul
      • Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
        • Korea Cancer Center Hospital
      • Hagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
        • Nowon Eulji Hospital
    • Paldal-gu, Suwon
      • Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
        • St. Vincent's Hospital
    • Pusan
      • Gaegeum-dong, Pusan, Korea, Republic of
        • Pusan Paik Hospital
    • Seo-gu, Pusan
      • Ami-dong, Seo-gu, Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Amnam-dong, Seo-gu, Pusan, Korea, Republic of
        • Kosin Medical Center
    • Seocho-gu, Seoul
      • Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
        • KangNam St. Mary's Hospital
    • Seodaemun-gu, Seoul
      • Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
        • Severance Hospital
    • Seoul
      • Jeo-dong, Seoul, Korea, Republic of
        • Seoul Paik Hospital
    • Songpa-gu, Seoul
      • Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
        • Samsung Medical Center
    • Sungbuk-ku, Seoul
      • Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
        • Korea University Anam Hospital
    • Yangcheon-gu, Seoul
      • Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
        • Ehwa Womans University Mokdong Hospital
    • Yongdeungpo-gu, Seoul
      • Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
        • KangNam Sacred Heart Hospital
    • Yongsan-gu, Seoul
      • Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of
        • Soon Chun Hyang University Hospital
    • Yungdungpo-Gu
      • Seoul, Yungdungpo-Gu, Korea, Republic of
        • 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. Patients who were between 18 and 60, inclusive.
  2. Patients with HBV DNA ³1 x 106 copies/mL within 30 days of baseline.
  3. Patients who were documented to be HBsAg positive for > 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).
  4. Patients who were HBeAg positive.
  5. Patients with ALT levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.
  6. Women of child bearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
  7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
  3. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
  4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patients co-infected with HCV, HDV or HIV.
  6. Patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/mL
  7. Patients who were pregnant or breast-feeding.
  8. Patients who were unwilling to use an "effective" method of contraception during the treatment and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. IUD, barrier methods with spermicide or abstinence)
  9. Patients with a clinically relevant history of abuse of alcohol or drugs.

  10. Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.

    The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.

  11. Patients with 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]

Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall 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) at Week 24
Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.

Secondary Outcome Measures

Outcome Measure
Efficacy:
Proportion of patients with HBV DNA below the assay Limit of Detection
Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
Proportion of ALT normalization

Collaborators and Investigators

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

Sponsor

Bukwang Pharmaceutical

Investigators

  • Principal Investigator: Hyo-Suk Lee, MD. PhD, Seoul National University Hospital

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

June 1, 2003

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

April 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-FMAU-301

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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