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Trial record 7 of 131 for:    "Hepatitis" | "Lamivudine"

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

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

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE December 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
HBV DNA titer < 300 copies/mL [ Time Frame: 48 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00798460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance [ Time Frame: 48 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
Official Title  ICMJE A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
Brief Summary The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE
  • Drug: adefovir
    adefovir 10mg
    Other Name: Hepsera
  • Drug: clevudine
    clevudine 30mg
    Other Name: Levovir
  • Drug: lamivudine
    lamivudine 100mg
    Other Name: Zeffix
Study Arms  ICMJE
  • Active Comparator: Lamivudine plus adefovir
    Interventions:
    • Drug: adefovir
    • Drug: lamivudine
  • Active Comparator: Clevudine plus adefovir
    Interventions:
    • Drug: adefovir
    • Drug: clevudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 22, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
70
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798460
Other Study ID Numbers  ICMJE IB-0809-055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party June Sung Lee, Ilsanpaik hospital, Inje University
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Bukwang Pharmaceutical
Investigators  ICMJE
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
PRS Account Inje University
Verification Date June 2011

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