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

Sponsor:	Inje University
Collaborator:	Bukwang Pharmaceutical
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00798460

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: adefovir Drug: clevudine Drug: lamivudine	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Adefovir Lamivudine Adefovir dipivoxil 2'-Fluoro-5-methyl-beta-L-arabinofuranosyluracil Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:

HBV DNA titer < 300 copies/mL [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	December 2008
Study Completion Date:	November 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lamivudine plus adefovir	Drug: adefovir adefovir 10mg Other Name: Hepsera Drug: lamivudine lamivudine 100mg Other Name: Zeffix
Active Comparator: Clevudine plus adefovir	Drug: adefovir adefovir 10mg Other Name: Hepsera Drug: clevudine clevudine 30mg Other Name: Levovir

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798460

Locations

Korea, Republic of
Ilsanpaik hospital
Goyang, Gyunggi, Korea, Republic of, 411-706

Sponsors and Collaborators

Inje University

Bukwang Pharmaceutical

Investigators

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

More Information

No publications provided

Responsible Party:	June Sung Lee, Ilsanpaik hospital, Inje University
ClinicalTrials.gov Identifier:	NCT00798460 History of Changes
Other Study ID Numbers:	IB-0809-055
Study First Received:	November 25, 2008
Last Updated:	June 22, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Inje University:

Chronic hepatitis B
lamivudine resistance
clevudine

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

2'-fluoro-5-methylarabinosyluracil
Adefovir
Adefovir dipivoxil
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012