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

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ClinicalTrials.gov Identifier: NCT02337127
Recruitment Status : Unknown
Verified January 2015 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Lamivudine Phase 4

Detailed Description:

The purposes of this study are:

  1. To evaluate the long-term efficacy of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
  2. To evaluate the long-term outcomes and predictive factors of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.

A prospective, open-label, multicenter study will enroll 500 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents. With their voluntary decision after consultation, 250 patients will receive Lamivudine extending therapy for 5 years and the other 250 patients will receive follow-up and serve as controls. The primary outcome measurement is HBV DNA recurrence, whilst the secondary outcome measurement is liver-related outcomes and associated predictive factors


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Multicenter Study of Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents
Study Start Date : June 2011
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine

Arm Intervention/treatment
Active Comparator: Arm A
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
Lamivudine, 100mg/day, per os
Other Name: Zeffix

No Intervention: Arm B
250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive follow-up.



Primary Outcome Measures :
  1. Rate of HBV DNA recurrence [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Associated predictive factors of HBV DNA recurrence [ Time Frame: up to 12 months ]
  2. Rate of drug resistant mutation [ Time Frame: up to 12 months ]
  3. Rate of clinical relapse in Group B (non-intervention) [ Time Frame: up to 12 months ]
    clinical relapse means HBV DNA>2000 IU/mL plus ALT > 2 fold upper limit of normal (ULN) in end of entecavir (ETV) normal alanine aminotransferase (ALT) or 2 fold elevation in end of ETV abnormal ALT patients


Other Outcome Measures:
  1. Rate of severe reactivation or death [ Time Frame: up to 12 months ]
    severe reactivation means alanine aminotransferase (ALT) > 10 fold upper limit of normal plus either total bilirubin > 2 mg/dL or prothrombin time prolong > 3 seconds



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients >=18 years of age
  2. Negative serum HBV DNA within 3 months prior to entry
  3. ALT <1.5 ULN within 3 months prior to entry
  4. 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.

Exclusion Criteria:

  1. Women with ongoing pregnancy or breast feeding
  2. 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
  3. Any investigational drug *6 weeks prior to the first dose of study drug
  4. Co-infection with active hepatitis A, hepatitis C and/or human immunodeficiency virus (HIV)
  5. Patients who have virological evidence of Lamivudine-associated YMDD mutants.
  6. Patients who have clinical evidence of liver cirrhosis or hepatocellular carcinoma.
  7. 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)
  8. Signs or symptoms of hepatocellular carcinoma
  9. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  10. Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
  11. Serum creatinine level >1.5 times the upper limit of normal at screening
  12. 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
  13. History of a severe seizure disorder or current anticonvulsant use
  14. 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
  15. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
  16. Inability or unwillingness to provide informed consent or abide by the requirements of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337127


Contacts
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Contact: Wan-Long Chuang waloch@kmu.edu.tw

Locations
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Taiwan
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital Recruiting
Kaohsiung, NRW, Taiwan
Contact: Wan-Long Chuang         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Wan-Long Chuang Kaohsiung Medical University Hospital, Internal Medicine

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02337127     History of Changes
Other Study ID Numbers: KMUH-IRB-20110187
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Lamivudine
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Anti-HIV Agents