NCT00926757

Brief Summary

Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

3.6 years

First QC Date

June 22, 2009

Last Update Submit

May 27, 2013

Conditions

Non Hodgkin's LymphomaHepatitis B

Keywords

lymphomaCD20Hepatitis B virusreactivationRituximab

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the incidence of HBV reactivation during and within 12 months after chemotherapy

    Monthly, and till 12 months after chemotherapy

Secondary Outcomes (1)

  • The incidence of HBsAg reverse seroconversion during and within 12 months after completing chemotherapy.

    monthly, till 12 months after chemotherapy

Study Arms (2)

Entecavir prophylaxis

EXPERIMENTAL

Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of chemotherapy, and will be continued until 3 months after completion of the chemotherapy.

Drug: Entecavir prophylaxis

Therapeutic arm

ACTIVE COMPARATOR

In patients with HBV reactivation and ALT flare \> 100 U/L, entecavir 0.5mg daily will be prescribed for the cases till hepatitis remission

Drug: Therapeutic entecavir

Interventions

Entecavir prophylaxisDRUG

Entecavir 0.5mg daily from day 1 of chemotherapy to 3 months after completing chemotherapy

Also known as: Baraclude
Entecavir prophylaxis
Therapeutic entecavirDRUG

Entecavir 0.5cm daily since hepatitis flare and HBV reactivation, till hepatitis remission

Also known as: Baraclude
Therapeutic arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CD20 positive lymphoma
  • negative for HBsAg and positive for anti-HBc
  • age over 16 years old
  • alanine aminotransferase less than 2 times the upper limit of normal
  • bilirubin \< 2.5 mg/dL
  • neutrophil \> 2000/mm3
  • platelet \> 100,000/mm3
  • creatinine \< 1.5 mg/dL
  • urea nitrogen \< 25 mg/dL
  • Eastern Cooperative Oncology Group performance score 0 to 2

You may not qualify if:

  • Child-Pugh class B or C cirrhosis
  • grade 2 or greater heart failure by the NYHA classification
  • previous chemotherapy,radiotherapy, or concurrent glucocorticoid therapy for other reasons
  • other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, or Wilsons' disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital-Division of Gastroenterology, Division of Oncology

Taipei, 11217, Taiwan

Location

Related Publications (1)

  • Huang YH, Hsiao LT, Hong YC, Chiou TJ, Yu YB, Gau JP, Liu CY, Yang MH, Tzeng CH, Lee PC, Lin HC, Lee SD. Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B. J Clin Oncol. 2013 Aug 1;31(22):2765-72. doi: 10.1200/JCO.2012.48.5938. Epub 2013 Jun 17.

    PMID: 23775967DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHepatitis BLymphoma

Interventions

entecavir

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Yi-Hsiang Huang, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yi-Hsiang Huang, Professor

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

TW(1)