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

This study has been terminated.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00313261
First received: April 11, 2006
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Drug: Clevudine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

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

Secondary Outcome Measures:
  • 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)

Study Start Date: June 2003
Estimated Study Completion Date: February 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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]

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313261

Locations
Korea, Republic of
Korea University Guro Hospital
Guro-dong, Guro-ku, Seoul, Korea, Republic of
Seoul National University
Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
Yongdong Severance Hospital
Dogok-dong, Kangnam-Gu, Seoul, Korea, Republic of
Samsung Medical Center
Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republic of
Asan Medical Center
Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of
Ewha Womans University Hospital
Mok-dong, Yangchon-Gu, Seoul, Korea, Republic of
St. Mary's Hospital
Youido, Yougdungpo-Gu, Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Hyo Suk Lee, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00313261     History of Changes
Other Study ID Numbers: L-FMAU-203
Study First Received: April 11, 2006
Last Updated: October 16, 2012
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
2'-fluoro-5-methylarabinosyluracil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014