Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy
Comparison of the Occurrence of HBV Reactivation According to the Duration of Preemptive Antiviral Therapy in Chronic Hepatitis B Virus Carriers Receiving Cancer Chemotherapy for Hematologic Diseases
연구 개요
상세 설명
HBV reactivation in cancer patients is important not only for directly affecting severe hepatic failure but also for delaying of the further cancer treatments which may cause reduction of overall survival. Thus the guidelines according to the previous studies and other follow-up of randomized studies revealed that patients with positive HbsAg should be administered with preemptive antiviral therapy at least 6 month or more.
However, ideal duration for preemptive antiviral therapy to suppress viral reactivation and withdrawal hepatitis is not clearly identified at present time. It is because previous data just dealt with the efficiency of preemptive antiviral therapy, but most of them did not analyze the outcomes after withdrawal of antiviral therapy. Frequent late-onset reactivation hepatitis in association with preemptive antiviral therapy is mainly due to drug-resistance or post-withdrawal manifestation. Drug-resistance was mainly associated with lamivudine which is now substituted by entecavir or tenofovir which produce lower incidence of resistance (< 1.2% at 6 years). Therefore, the only issue at present is withdrawal hepatitis which may be due to early cessation of the antiviral drug.
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 18 years old or older
- ECOG performance status 0, 1, 2
- Hodgkin's or Non-Hodgkins lymphomas according to the WHO 2008 classification
- Patients who received standard cytotoxic chemotherapies
- Patients who finished chemotherapy (duration not exceeded 6 months) or who will finish the planned chemotherapy
- Patients who achieved at least partial response and do not need further chemotherapy
- HBsAg (+) patients who received preemptive antiviral therapies
Exclusion Criteria:
- Anti-HCV Ab(+), HIV(+), or autoimmune hepatitis
- Complications due to uncompensated liver cirrhosis
- Child pugh score : 10 points or more
- Hepatocellular carcinoma
- Patients who finish the lymphoma treatments with only radiotherapy
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Cumulative incidence rate of hepatitis B viral reactivation
기간: within one year after cessation of the antiviral drug
|
within one year after cessation of the antiviral drug
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severity of reactivation of hepatitis B
기간: within one year after cessation of anviral drugs
|
Severity according to ALT (IU/L) level Mild : up to 5 times from upper normal limit Moderate : 5- 10 times from upper normal limit Severe : ALT > 300 IU/L or ≥ 10 times
|
within one year after cessation of anviral drugs
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHSCTC-R01-HEPATO
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