Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

January 30, 2017 updated by: Bukwang Pharmaceutical

An Open-label, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial

The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.

Study Overview

Status

Completed

Conditions

Study Type

Observational

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
    • Daegu
      • Jung-gu,, Daegu, Korea, Republic of
        • Keimyumg University Dongsan Medical Center
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of
        • Korea University Guro Hospital
    • Incheon
      • Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
        • St. Mercy's Hospital
      • Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
        • Inha University Hospital
    • Jeonbuk
      • Iksan-City, Jeonbuk, Korea, Republic of
        • Wonkwang University Hospital
      • Jeonju-city, Jeonbuk, Korea, Republic of
        • Chonbuk National University Hospital
    • Jongno-Gu
      • Seoul, Jongno-Gu, Korea, Republic of
        • Seoul National University Hospital
    • 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
    • Namdong-Gu
      • Incheon, Namdong-Gu, Korea, Republic of
        • Gil Medical Center
    • Nowon-gu, Seoul
      • Hagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
        • Nowon Eulji Hospital
    • Pusan
      • Ami-dong, Seo-gu, Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Amnam-dong, Seo-gu, Pusan, Korea, Republic of
        • Kosin Medical Center
    • Seoul
      • Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
        • KangNam Sacred Heart Hospital
      • Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
        • Yongdong Severance Hospital
      • Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
        • Korea Cancer Center Hospital
      • Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
        • Samsung Medical Center
      • Jeo-dong, Seoul, Korea, Republic of
        • Seoul Paik Hospital
      • Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
        • Ehwa Womans University Mokdong Hospital
      • Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
        • Seoul ASAN Medical Center
      • Pyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
        • Severance Hospital
    • Suwon
      • Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
        • St. Vincent's Hospital
    • Taegu
      • Daemyoung-dong, Nam-gu, Taegu, Korea, Republic of
        • Yeungnam University Medical Center
    • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the patients who completed the previous 301, 302 and 303 studies with clevudine

Description

Inclusion Criteria:

  1. The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
  2. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
  3. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
  4. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
  5. Patients with 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 at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.

Exclusion Criteria:

  1. Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
  2. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  3. Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
  4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patients co-infected with HCV, HDV or HIV.
  6. Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.
  7. Patients who were pregnant or breast-feeding.
  8. Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, 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.
  9. Patients who were not suitable to the study if judged by an investigator.

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

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, 2005

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLV-304

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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