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

This study has been terminated.
(could not enroll patients)
Sponsor:
Collaborator:
Bukwang Pharmaceutical
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00798460
First received: November 25, 2008
Last updated: June 22, 2011
Last verified: June 2011

November 25, 2008
June 22, 2011
December 2008
June 2010   (final data collection date for primary outcome measure)
HBV DNA titer < 300 copies/mL [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00798460 on ClinicalTrials.gov Archive Site
Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: adefovir
    adefovir 10mg
    Other Name: Hepsera
  • Drug: clevudine
    clevudine 30mg
    Other Name: Levovir
  • Drug: lamivudine
    lamivudine 100mg
    Other Name: Zeffix
  • Active Comparator: Lamivudine plus adefovir
    Interventions:
    • Drug: adefovir
    • Drug: lamivudine
  • Active Comparator: Clevudine plus adefovir
    Interventions:
    • Drug: adefovir
    • Drug: clevudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
November 2010
June 2010   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00798460
IB-0809-055
Yes
June Sung Lee, Ilsanpaik hospital, Inje University
Inje University
Bukwang Pharmaceutical
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
Inje University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP