Status:
TERMINATED
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
Lead Sponsor:
Inje University
Collaborating Sponsors:
Bukwang Pharmaceutical
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 incid...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00798460
Start Date
December 1 2008
End Date
November 1 2010
Last Update
June 23 2011
Active Locations (1)
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1
Ilsanpaik hospital
Goyang, Gyunggi, South Korea, 411-706