Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy
|ClinicalTrials.gov Identifier: NCT02056548|
Recruitment Status : Unknown
Verified February 2014 by Jae-Ho, Yoon, Seoul St. Mary's Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
|Condition or disease|
|Lymphoma Chronic Hepatitis B|
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.
|Study Type :||Observational|
|Estimated Enrollment :||126 participants|
|Observational Model:||Case Control|
|Official Title:||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|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
- Cumulative incidence rate of hepatitis B viral reactivation [ Time Frame: within one year after cessation of the antiviral drug ]
- Severity of reactivation of hepatitis B [ Time Frame: 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
Biospecimen Retention: Samples With DNA