Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus

This study has been terminated.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00305019
First received: March 17, 2006
Last updated: April 11, 2006
Last verified: April 2006
  Purpose

The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).


Condition Intervention Phase
Hepatitis B
Drug: clevudine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Efficacy: Change from baseline in HBV DNA (log10)

Secondary Outcome Measures:
  • Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
  • Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
  • Proportion of patients with hepatitis Be antigen (HBeAg) loss
  • Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
  • Biochemical improvement (e.g., ALT normalization)
  • Safety
  • Laboratory tests
  • Adverse Events
  • Vital Signs
  • Electrocardiogram (ECG)

Estimated Enrollment: 120
Study Start Date: July 2002
Estimated Study Completion Date: March 2004
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who is between 18 and 60 years of age, inclusive
  2. Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.
  3. Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.

    Evidence of HBsAg (+) for the previous 6 months may include the following:

    • documentation of HBsAg (+) for the previous 6 months
    • documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
    • IgM anti-HBc negative and IgG anti-HBc positive at screening
  4. Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
  5. Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
  6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
  7. Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:

    • have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
    • continue with period 1 log10 decrease in HBV DNA from baseline.

Exclusion Criteria:

  1. Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
  3. Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
  4. Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
  6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
  7. Patient who is pregnant or breast-feeding.
  8. Patient who is unwilling to use an “effective” method of contraception during the study and for up to 30 days 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., intrauterine device [IUD], barrier methods with spermicide or abstinence)
  9. Patient who has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Patient who has creatinine clearance less than 60 mL/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]

Patients found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.

  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: NCT00305019

Locations
Korea, Republic of
Korea University Guro Hospital
Guro-dong, Guro-ku, Seoul, Korea, Republic of, 152-703
Seoul National University
Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of, 110-744
Kangdong Sacred Heart Hospital
Gil-dong, Kangdong-Gu, Seoul, Korea, Republic of, 134-701
Yongdong Severance Hospital
Dogok-dong, Kangnam-Gu, Seoul, Korea, Republic of, 146-92
Samsung Medical Center
Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710
Asan Medical Center
Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of, 388-1
Ewha Womans University Hospital
Mok-dong, Yangchon-Gu, Seoul, Korea, Republic of, 911-1
St. Mary’s Hospital
Youido, Yougdungpo-Gu, Seoul, Korea, Republic of, 150-713
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Hyo Suk Lee, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided by Bukwang Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00305019     History of Changes
Other Study ID Numbers: L-FMAU-201
Study First Received: March 17, 2006
Last Updated: April 11, 2006
Health Authority: Korea: Food and Drug Administration

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 21, 2014