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

This study has been terminated.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00362700
First received: August 8, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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 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 Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201

Resource links provided by NLM:


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 National University Hospital
28 Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
Korea University Guro Hospital
80 Guro-dong, Gro-gu, Seoul, Korea, Republic of
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Samsung Medical Center
Ilwon-dong, Songpa-gu, 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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00362700     History of Changes
Other Study ID Numbers: L-FMAU-204
Study First Received: August 8, 2006
Last Updated: August 8, 2006
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 15, 2014