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Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Jae-Ho, Yoon, Seoul St. Mary's Hospital

Brief Summary:
Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Based on the study results, guidelines recommend that preemptive antiviral therapy should be maintained for at least 6 months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or longer after final chemotherapy without definite evidences, and this practice increases the medical expenditure a lot. Therefore, the investigators are going to find out the proper and safe duration of preemptive antiviral therapy which can be a good reference in the future practice.

Condition or disease
Lymphoma Chronic Hepatitis B

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. Cumulative incidence rate of hepatitis B viral reactivation [ Time Frame: within one year after cessation of the antiviral drug ]

Secondary Outcome Measures :
  1. 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
Whole blood

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic hepatitis B patients who will be newly diagnosed as malignant lymphomas and receive standard chemotherapies at Seoul St. Mary's Hospital in Korea.

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
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Responsible Party: Jae-Ho, Yoon, Clinical fellowship in Catholic BMT Center, Seoul St. Mary's Hospital Identifier: NCT02056548    
Other Study ID Numbers: CHSCTC-R01-HEPATO
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Keywords provided by Jae-Ho, Yoon, Seoul St. Mary's Hospital:
preemptive antiviral treatment
chronic hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections