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

Primary Purpose

Chronic Hepatitis B

Status

Terminated

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

adefovir

clevudine

lamivudine

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B, lamivudine resistance, clevudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

Ilsanpaik hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lamivudine plus adefovir

Clevudine plus adefovir

Arm Description

Outcomes

Primary Outcome Measures

HBV DNA titer < 300 copies/mL

Secondary Outcome Measures

Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance

Full Information

NCT ID

NCT00798460

First Posted

November 25, 2008

Last Updated

June 22, 2011

Sponsor

Inje University

Collaborators

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00798460

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Terminated

Why Stopped

could not enroll patients

Study Start Date

December 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Inje University

Collaborators

Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

Chronic hepatitis B, lamivudine resistance, clevudine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lamivudine plus adefovir

Arm Type

Active Comparator

Arm Title

Clevudine plus adefovir

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

adefovir

Other Intervention Name(s)

Hepsera

Intervention Description

adefovir 10mg

Intervention Type

Drug

Intervention Name(s)

clevudine

Other Intervention Name(s)

Levovir

Intervention Description

clevudine 30mg

Intervention Type

Drug

Intervention Name(s)

lamivudine

Other Intervention Name(s)

Zeffix

Intervention Description

lamivudine 100mg

Primary Outcome Measure Information:

Title

HBV DNA titer < 300 copies/mL

Time Frame

48 week

Secondary Outcome Measure Information:

Title

Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance

Time Frame

48 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

June Sung Lee, M.D.

Organizational Affiliation

Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ilsanpaik hospital

City

Goyang

State/Province

Gyunggi

ZIP/Postal Code

411-706

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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