Efficacy of Clevudine Plus Lamivudine for Lamivudine-Resistant Chronic Hepatitis B Patients
Information source: Inje University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: adefovir (Drug); clevudine (Drug); lamivudine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Inje University Official(s) and/or principal investigator(s):
June Sung Lee, M.D., Principal Investigator, Affiliation: Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706
Overall contact:
June Sung Lee, M.D., Phone: 82-31-910-7823, Email: jsleemd@paik.ac.kr
Summary
The purpose of this study is to determine the optimal antiviral treatment for lamivudine
resistant hepatitis B patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: HBV DNA titer < 300 copies/mL
Secondary outcome: Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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%
Locations and Contacts
June Sung Lee, M.D., Phone: 82-31-910-7823, Email: jsleemd@paik.ac.kr
Ilsanpaik hospital, Goyang, Gyunggi 411-706, Korea, Republic of; Recruiting
June Sung Lee, M.D., Phone: 82-31-910-7823, Email: jsleemd@paik.ac.kr
June Sung Lee, M.D., Principal Investigator
Additional Information
Starting date: December 2008
Last updated: February 3, 2009
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