Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Labeled, Multicenter Study Comparing Entecavir Versus Lamivudine as Antiviral Prophylaxis for Patients With Hepatitis B Infection Undergoing Cytotoxic Chemotherapy for Malignant Tumors|
- The cumulative probability of HBV reactivation [ Time Frame: From the time of randomization until 24week after discontinuation of antiviral prophylaxis ] [ Designated as safety issue: No ]10-fold or more elevation in serum HBV DNA titers above nadir
- Incidence of HBV-related hepatitis flare [ Time Frame: From the time of randomization until 24week after discontinuation of antiviral prophylaxis ] [ Designated as safety issue: No ]greater than 3-fold increase of ULN (upper limit of a normal reference value) of a serum ALT level that exceeded 100 IU/L during antiviral prophylaxis and 24 week after discontinuation of antiviral prophylaxis
- Cumulative probability of emergence of genotypic resistance [ Time Frame: From the time of randomization until 24week after discontinuation of antiviral prophylaxis ] [ Designated as safety issue: No ]detection of mutations that have been shown in in vitro studies to confer resistance to either ETV or LAM
- Incidence of hepatic decompensation and liver-related mortality [ Time Frame: From the time of randomization until 24week after discontinuation of antiviral prophylaxis ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Lamivudine
LAM (100 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.
lamivudine 100mg daily per os
ETV (0.5 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.
Entecavir 0.5mg daily per os
Chronic hepatitis B virus (HBV) carriers who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare, and lamivudine (LAM) prophylaxis is recommended according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis defined as virologic breakthrough during LAM therapy and withdrawal hepatitis after discontinuation of LAM therapy occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Considering that LAM therapy showed relatively higher rates of drug resistance and of withdrawal hepatitis, studies on the better choice of prophylactic antiviral regimen is warranted.
The purpose of our study is to conduct a multicenter, prospective, randomized study comparing the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.
A total one hundred eighty HBV carriers with malignancy undergoing chemotherapy will be randomly assigned to each prophylactic therapy arm of ETV and LAM group. The primary endpoint of the study is the HBV reactivation rate during antiviral therapy and 6 months after discontinuation of prophylactic antiviral therapy.
If the prophylactic efficacy of ETV is superior to that of LAM, ETV will be the preferred prophylactic therapy for HBsAg-positive cancer patients undergoing chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580202
|Contact: Sook-Hyang Jeong, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center, Korea||Recruiting|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Contact: Bo Hyun Kim, MD, PhD email@example.com|
|Principal Investigator: Bo Hyun Kim, MD, PhD|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam, Gyeonggi, Korea, Republic of, 463-707|
|Contact: Sook-Hyang Jeong firstname.lastname@example.org|
|Principal Investigator: Sook-Hyang Jeong, MD, PhD|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jeong-Hoon Lee, MD, PhD email@example.com|
|Principal Investigator: Jeong-Hoon Lee, MD, PhD|
|Seoul National University Boramae Hospital||Recruiting|
|Seoul, Korea, Republic of, 156-707|
|Contact: Won Kim, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Won Kim, MD, PhD|
|Principal Investigator:||Sook-Hyang Jeong, MD, PhD||Seoul National University Bundang Hospital|