Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

NCT02337127 | Unknown Phase 4

• 1 other identifier: KMUH-IRB-20110187
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Rate of HBV DNA recurrence

  up to 12 months

Secondary Outcomes (3)

• Associated predictive factors of HBV DNA recurrence

  up to 12 months

• Rate of drug resistant mutation

  up to 12 months

• Rate of clinical relapse in Group B (non-intervention)

  up to 12 months

Other Outcomes (1)

• Rate of severe reactivation or death

  up to 12 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive Lamivudine extending therapy for 5 years.

Drug: Lamivudine

Arm B

NO INTERVENTION

250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive follow-up.

Interventions

Lamivudine DRUG

Lamivudine, 100mg/day, per os

Also known as: Zeffix

Arm A

Eligibility Criteria

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

You may qualify if:

• Male and female patients \>=18 years of age
• Negative serum HBV DNA within 3 months prior to entry
• ALT \<1.5 ULN within 3 months prior to entry
• Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females of the Lamivudine treatment arm must be using reliable contraception during the study and for 6 months after treatment completion.

You may not qualify if:

• Women with ongoing pregnancy or breast feeding
• Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug
• Any investigational drug \*6 weeks prior to the first dose of study drug
• Co-infection with active hepatitis A, hepatitis C and/or human immunodeficiency virus (HIV)
• Patients who have virological evidence of Lamivudine-associated YMDD mutants.
• Patients who have clinical evidence of liver cirrhosis or hepatocellular carcinoma.
• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Signs or symptoms of hepatocellular carcinoma
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
• Serum creatinine level \>1.5 times the upper limit of normal at screening
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• History of a severe seizure disorder or current anticonvulsant use
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital

Kaohsiung City, NRW, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

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

• Wan-Long Chuang

  Kaohsiung Medical University Hospital, Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Long Chuang

CONTACT

waloch@kmu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: January 13, 2015
• Study Start: June 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

TW (1)