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Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

This study has been terminated.

Sponsored by: Bukwang Pharmaceutical
Information provided by: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT00362700
  Purpose

The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine


Condition Intervention Phase
Hepatitis B
Drug: Clevudine
Phase II

MedlinePlus related topics:   Hepatitis    Hepatitis B   

ChemIDplus related topics:   Hepatitis B Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201

Further study details as provided by Bukwang Pharmaceutical:

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

Secondary Outcome Measures:
  • Antiviral activity- 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)

Estimated Enrollment:   33
Study Start Date:   July 2003
Estimated Study Completion Date:   October 2005

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

Criteria

Inclusion Criteria:

  1. Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
  2. Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy.
  3. Patient is 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. HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
  2. Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
  3. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
  4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient is coinfected with HCV, HDV or HIV.
  6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
  7. Patient is pregnant or breast-feeding.
  8. Patient is unwilling to use an “effective” method of contraception during the study and for up to 3 months after the use of study drug ceases. 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 spermicide or abstinence)
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Patient has 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: NCT00362700

Locations
Korea, Republic of, Seoul
Ehwa Womans University Mokdong Hospital    
      Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Korea University Guro Hospital    
      80 Guro-dong, Gro-gu, Seoul, Korea, Republic of
Samsung Medical Center    
      Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center    
      Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Seoul National University Hospital    
      28 Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
Yongdong Severance Hospital    
      Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Korea, Republic of, Songpa-Gu, Seoul
Asan Medical Center    
      Pungnab2-dong, Songpa-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


Study ID Numbers:   L-FMAU-204
First Received:   August 8, 2006
Last Updated:   August 8, 2006
ClinicalTrials.gov Identifier:   NCT00362700
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:
Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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