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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00362674
First received: August 8, 2006
Last updated: December 21, 2010
Last verified: December 2010
  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 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Study Start Date: June 2005
  Eligibility

Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

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

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Hun Jun Jang, Bukwang Pharm.
ClinicalTrials.gov Identifier: NCT00362674     History of Changes
Other Study ID Numbers: CLV-304
Study First Received: August 8, 2006
Last Updated: December 21, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Clevudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014