Trial record 33 of 446 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Jae-Ho, Yoon, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT02056548
First received: February 3, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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
Lymphoma
Chronic Hepatitis B

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Cumulative incidence rate of hepatitis B viral reactivation [ Time Frame: within one year after cessation of the antiviral drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of reactivation of hepatitis B [ Time Frame: within one year after cessation of anviral drugs ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 126
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jae-Ho, Yoon, Clinical fellowship in Catholic BMT Center, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02056548     History of Changes
Other Study ID Numbers: CHSCTC-R01-HEPATO
Study First Received: February 3, 2014
Last Updated: February 4, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul St. Mary's Hospital:
preemptive antiviral treatment
lymphoma
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hematologic Diseases
Lymphoma
Hematologic Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014