Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group

October 16, 2012 updated by: Bukwang Pharmaceutical

An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group

The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

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
        • Korea University Guro Hospital
    • Jongno-Gu, Seoul
      • Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
        • Seoul National University
    • Kangnam-Gu, Seoul
      • Dogok-dong, Kangnam-Gu, Seoul, Korea, Republic of
        • Yongdong Severance Hospital
      • Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republic of
        • Samsung Medical Center
    • Songpa-Gu, Seoul
      • Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of
        • Asan Medical Center
    • Yangchon-Gu, Seoul
      • Mok-dong, Yangchon-Gu, Seoul, Korea, Republic of
        • Ewha Womans University Hospital
    • Yougdungpo-Gu, Seoul
      • Youido, Yougdungpo-Gu, Seoul, 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who received placebo in L-FMAU-201 study
  2. Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy.
  3. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
  4. Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60:

1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48

Exclusion Criteria:

  1. Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study.
  2. Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  3. Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
  4. Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient who was co-infected with HCV, HDV or HIV.
  6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
  7. Patient who was pregnant or breast-feeding.
  8. Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. 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., IUD, barrier methods with supermicide or abstinence)
  9. Patient who had a clinically relevant history of abuse of alcohol or drugs.
  10. Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Patient who had 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]

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy: Change from baseline in HBV DNA (log10)
Safety: Laboratory tests, Adverse Events, Vital Signs, ECG

Secondary Outcome Measures

Outcome Measure
Efficacy
Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
Biochemical improvement (ALT normalization)
Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)

Collaborators and Investigators

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

Sponsor

Bukwang Pharmaceutical

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

February 1, 2005

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)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-FMAU-203

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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