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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305019
Recruitment Status : Terminated
First Posted : March 21, 2006
Last Update Posted : April 12, 2006
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Drug: clevudine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2002
Study Completion Date : March 2004

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305019

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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
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Principal Investigator: Hyo Suk Lee, M.D., Ph.D. Seoul National University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00305019    
Other Study ID Numbers: L-FMAU-201
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: April 12, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents