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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00798460
• Other study ID #: IB-0809-055
• Status: Terminated
• Phase: Phase 4
• First received: November 25, 2008
• Last updated: June 22, 2011
• Start date: December 2008
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• adefovir
adefovir 10mg
• clevudine
clevudine 30mg
• lamivudine
lamivudine 100mg

Locations

Country	Name	City	State
Korea, Republic of	Ilsanpaik hospital	Goyang	Gyunggi

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA titer < 300 copies/mL		48 week	Yes
Secondary	Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance		48 week	Yes