NCT01580202

Brief Summary

Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in such circumstance according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM, studies on the proper prophylactic antiviral regimen is warranted. The present multicenter, prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

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, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

5.2 years

First QC Date

April 4, 2012

Last Update Submit

June 28, 2017

Conditions

MalignancyHepatitis B

Keywords

malignancyhepatitis Blamivudineentecavirprophylaxis

Outcome Measures

Primary Outcomes (1)

  • The cumulative probability of HBV reactivation

    10-fold or more elevation in serum HBV DNA titers above nadir

    From the time of randomization until 24week after discontinuation of antiviral prophylaxis

Secondary Outcomes (3)

  • Incidence of HBV-related hepatitis flare

    From the time of randomization until 24week after discontinuation of antiviral prophylaxis

  • Cumulative probability of emergence of genotypic resistance

    From the time of randomization until 24week after discontinuation of antiviral prophylaxis

  • Incidence of hepatic decompensation and liver-related mortality

    From the time of randomization until 24week after discontinuation of antiviral prophylaxis

Study Arms (2)

Lamivudine

ACTIVE COMPARATOR

LAM (100 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.

Drug: Lamivudine

Entecavir

EXPERIMENTAL

ETV (0.5 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.

Drug: Entecavir

Interventions

EntecavirDRUG

Entecavir 0.5mg daily per os

Entecavir
LamivudineDRUG

lamivudine 100mg daily per os

Lamivudine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • positive for HBsAg for at least 6 months
  • inactive or active carrier of HBV with ALT level \<2xULN, chronic hepatitis and compensated cirrhosis (Child-Pugh class A)
  • malignant tumors: non-Hodgkin's lymphoma undergoing systemic chemotherapy; solid tumors undergoing chemotherapy (including adjuvant/neoadjuvant chemotherapy or concurrent chemoradiation therapy)

You may not qualify if:

  • positive for anti-HCV or anti-HIV antibodies
  • decompensated cirrhosis or hepatocellular carcinoma
  • expected survival of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Seoul National University Boramae Hospital

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

NeoplasmsHepatitis B

Interventions

entecavirLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Sook-Hyang Jeong, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Locations

KR(5)