ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

This study is ongoing, but not recruiting participants.

Sponsored by: Bukwang Pharmaceutical
Information provided by: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT00362674
  Purpose

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.


Condition Phase
Hepatitis B
Phase III

MedlinePlus related topics:   Hepatitis    Hepatitis B   

ChemIDplus related topics:   Hepatitis B Vaccines   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:   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

Further study details as provided by Bukwang Pharmaceutical:

Study Start Date:   June 2005

  Eligibility
Genders Eligible for Study:   Both

Criteria

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 postivie 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362674

Locations
Korea, Republic of, Daegu
Keimyumg University Dongsan Medical Center    
      Jung-gu,, Daegu, Korea, Republic of
Korea, Republic of, Incheon
Gil Medical Center    
      1198 Guwol-dong, Namdong-Gu, Incheon, Korea, Republic of
Inha University Hospital    
      Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
St. Mercy’s Hospital    
      Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Korea, Republic of, Jeonbuk
Chonbuk National University Hospital    
      Jeonju-city, Jeonbuk, Korea, Republic of
Wonkwang University Hospital    
      Iksan-City, Jeonbuk, Korea, Republic of
Korea, Republic of, Kyounggi-do
National Cancer Center    
      Ilsan-gu, Kyounggi-do, Korea, Republic of
Pochon CHA University Hospital    
      Seongnam-gu, Kyounggi-do, Korea, Republic of
St. Holly Family Mary’s Hospital    
      2 sosa-dong, Wonmi-Gu, Pucheon, Kyounggi-do, Korea, Republic of
Korea, Republic of, Nowon-gu, Seoul
Nowon Eulji Hospital    
      Hagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
Korea, Republic of, Pusan
Kosin Medical Center    
      Amnam-dong, Seo-gu, Pusan, Korea, Republic of
Pusan National University Hospital    
      Ami-dong, Seo-gu, Pusan, Korea, Republic of
Korea, Republic of, Seoul
Ehwa Womans University Mokdong Hospital    
      Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Kangbuk Samsung Hospital    
      Pyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital    
      Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Korea Cancer Center Hospital    
      Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
Korea University Anam Hospital    
      Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
Seoul Asan Medical Center    
      Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Samsung Medical Center    
      Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Korea University Guro Hospital    
      80 Guro-dong, Gro-gu, Seoul, Korea, Republic of
Seoul National University Hospital    
      28 Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
Seoul Paik Hospital    
      Jeo-dong, Seoul, Korea, Republic of
Severance Hospital    
      Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
St. Mary’s Hospital    
      62 Yeouido, Yungdungpo-Gu, Seoul, Korea, Republic of
Yongdong Severance Hospital    
      Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Korea, Republic of, Suwon
St. Vincent’s Hospital    
      Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
Korea, Republic of, Taegu
Yeungnam University Medical Center    
      Daemyoung-dong, Nam-gu, Taegu, Korea, Republic of

Sponsors and Collaborators
Bukwang Pharmaceutical

Investigators
Principal Investigator:     Hyo-suk Lee, MD. PhD.     Seoul National University Hospital    
  More Information


Study ID Numbers:   CLV-304
First Received:   August 8, 2006
Last Updated:   August 8, 2006
ClinicalTrials.gov Identifier:   NCT00362674
Health Authority:   South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers