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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Lamivudine||Phase 4|
The purposes of this study are:
- To evaluate the long-term efficacy of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Rate of HBV DNA recurrence [ Time Frame: up to 12 months ]
- Associated predictive factors of HBV DNA recurrence [ Time Frame: up to 12 months ]
- Rate of drug resistant mutation [ Time Frame: up to 12 months ]
- 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
- 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
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
|Contact: Wan-Long Chuangfirstname.lastname@example.org|
|Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital||Recruiting|
|Kaohsiung, NRW, Taiwan|
|Contact: Wan-Long Chuang|
|Principal Investigator:||Wan-Long Chuang||Kaohsiung Medical University Hospital, Internal Medicine|