Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

January 8, 2017 updated by: Jun Zhu, Peking University
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 4

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
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute
        • Sub-Investigator:
          • Yuqin Song
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Recruiting
        • 307 Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • 309 Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • Aerospace Central Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Air Force General Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • General Hospital of Chinese People's Liberation Army

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • treatment-naive patients with lymphoma
  • HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline
  • treated with chemotherapy and/or immunosuppressive therapy
  • life expectancy of more than 3 months

Exclusion Criteria:

  • younger than 18 years old
  • HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
  • pregnant or lactating women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Entecavir prophylaxis
Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy.
Drug: Entecavir prophylaxis
Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy
Other Names:
  • Baraclude
Active Comparator: Observation arm
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
Drug: Observation arm
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
Other Names:
  • Therapeutic entecavir group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
Time Frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence of hepatitis B virus maintained response, the incidence of hepatitis B virus sustained response, the incidence of hepatitis B virus relapse and hepatitis B virus relapse related hepatitis
Time Frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy

Collaborators and Investigators

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

Sponsor

Peking 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

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU-2012111305

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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