Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

July 31, 2013 updated by: Ye Guo, Fudan University

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously untreated NHL suitable for CHOP/R-CHOP treatment
  • Age range 18-80 years old
  • HBsAg positive with high level of HBV DNA
  • Eastern Cooperative Oncology Group performance status 0-2
  • Life expectancy of more than 3 months
  • Adequate organ function

Exclusion Criteria:

  • Primary or secondary central nervous system involvement
  • With hepatitis C virus infection
  • Previous serious cardiac disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: entecavir
entecavir 0.5 mg/day PO
Drug: Entecavir
entecavir 0.5 mg/day PO
Other Names:
  • baraclude
Drug: Lamivudine
lamivudine 100 mg/day PO
Other Names:
  • epivir
ACTIVE_COMPARATOR: lamivudine
lamivudine 100 mg/day PO
Drug: Entecavir
entecavir 0.5 mg/day PO
Other Names:
  • baraclude
Drug: Lamivudine
lamivudine 100 mg/day PO
Other Names:
  • epivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of HBV reactivation
Time Frame: 12 months
Defined by increased level of HBV DNA
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Time Frame: 6 months
Defined by increased level of alanine transaminase
6 months
Incidence rate and median time of treatment delay due to hepatitis
Time Frame: 6 months
Measured by information of treatment delay
6 months
Incidence rate and median time of HBV DNA level normalization
Time Frame: 6 months
Measured by information of HBV DNA level normalization
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of drug resistance of viral variants
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

March 2, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMTG 13-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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