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Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients

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: NCT00798460
Recruitment Status : Terminated (could not enroll patients)
First Posted : November 26, 2008
Last Update Posted : June 23, 2011
Bukwang Pharmaceutical
Information provided by:
Inje University

Brief Summary:
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: adefovir Drug: clevudine Drug: lamivudine Phase 4

Detailed Description:

Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.

In detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
Study Start Date : December 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine

Arm Intervention/treatment
Active Comparator: Lamivudine plus adefovir Drug: adefovir
adefovir 10mg
Other Name: Hepsera

Drug: lamivudine
lamivudine 100mg
Other Name: Zeffix

Active Comparator: Clevudine plus adefovir Drug: adefovir
adefovir 10mg
Other Name: Hepsera

Drug: clevudine
clevudine 30mg
Other Name: Levovir

Primary Outcome Measures :
  1. HBV DNA titer < 300 copies/mL [ Time Frame: 48 week ]

Secondary Outcome Measures :
  1. Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance [ Time Frame: 48 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HBsAg positive and anti-HBs negative more than 6 months
  • YMDD mutation (+)during lamivudine therapy
  • Serum ALT more than two times upper normal value

Exclusion Criteria:

  • HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
  • The sign of decompensated liver disease
  • Pregnant or lactating woman
  • The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
  • Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
  • Serum creatinine more than 1.5 times upper normal limit value
  • The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%

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): NCT00798460

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Korea, Republic of
Ilsanpaik hospital
Goyang, Gyunggi, Korea, Republic of, 411-706
Sponsors and Collaborators
Inje University
Bukwang Pharmaceutical
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Principal Investigator: June Sung Lee, M.D. Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706
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Responsible Party: June Sung Lee, Ilsanpaik hospital, Inje University Identifier: NCT00798460    
Other Study ID Numbers: IB-0809-055
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Inje University:
Chronic hepatitis B
lamivudine resistance
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents