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

NCT00798460 | Terminated Phase 4 DMC

• 1 other identifier: IB-0809-055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B; lamivudine resistance; clevudine

Outcome Measures

Primary Outcomes (1)

• HBV DNA titer < 300 copies/mL

  48 week

Secondary Outcomes (1)

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

  48 week

Study Arms (2)

Lamivudine plus adefovir

ACTIVE COMPARATOR

Drug: adefovir; Drug: lamivudine

Clevudine plus adefovir

ACTIVE COMPARATOR

Drug: adefovir; Drug: clevudine

Interventions

adefovir DRUG

adefovir 10mg

Also known as: Hepsera

Clevudine plus adefovir; Lamivudine plus adefovir

clevudine DRUG

clevudine 30mg

Also known as: Levovir

Clevudine plus adefovir

lamivudine DRUG

lamivudine 100mg

Also known as: Zeffix

Lamivudine plus adefovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg positive and anti-HBs negative more than 6 months
• YMDD mutation (+)during lamivudine therapy
• Serum ALT more than two times upper normal value

You may not qualify if:

• 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%

Sponsors & Collaborators

• Inje University: lead
• Bukwang Pharmaceutical: collaborator

Study Sites (1)

Ilsanpaik hospital

Goyang, Gyunggi, 411-706, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir; adefovir dipivoxil; clevudine; Lamivudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• June Sung Lee, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

KR (1)