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

Primary Purpose

Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir prophylaxis
Observation arm
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Cancer Hospital & InstituteRecruiting
  • 307 Hospital of the Chinese People's Liberation ArmyRecruiting
  • 309 Hospital of the Chinese People's Liberation ArmyRecruiting
  • Aerospace Central HospitalRecruiting
  • Air Force General Hospital of the Chinese People's Liberation ArmyRecruiting
  • Beijing HospitalRecruiting
  • Cancer Institute & Hospital, Chinese Academy of Medical SciencesRecruiting
  • First Hospital affiliated to General Hospital of the Chinese People's Liberation ArmyRecruiting
  • General Hospital of Chinese People's Liberation ArmyRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entecavir prophylaxis

Observation arm

Arm Description

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.

Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Outcomes

Primary Outcome Measures

the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2013
Last Updated
January 8, 2017
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01765231
Brief Title
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
Official Title
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Entecavir prophylaxis
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation arm
Arm Type
Active Comparator
Arm Description
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
Intervention Type
Drug
Intervention Name(s)
Entecavir prophylaxis
Other Intervention Name(s)
Baraclude
Intervention Description
Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy
Intervention Type
Drug
Intervention Name(s)
Observation arm
Other Intervention Name(s)
Therapeutic entecavir group
Intervention Description
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhu
Email
zj@bjcancer.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqin Song
Email
songyuqin622@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital & Institute
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Email
zj@bjcancer.org
First Name & Middle Initial & Last Name & Degree
Yuqin Song
Email
songyuqin622@sina.com
First Name & Middle Initial & Last Name & Degree
Yuqin Song
Facility Name
307 Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijing Zhang
First Name & Middle Initial & Last Name & Degree
Weijing Zhang
Facility Name
309 Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Ye
First Name & Middle Initial & Last Name & Degree
Liping Ye
Facility Name
Aerospace Central Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Wang
First Name & Middle Initial & Last Name & Degree
Jingbo Wang
Facility Name
Air Force General Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Xue
First Name & Middle Initial & Last Name & Degree
Mei Xue
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu
First Name & Middle Initial & Last Name & Degree
Hui Liu
Facility Name
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
Facility Name
First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxiong Wu
First Name & Middle Initial & Last Name & Degree
Xiaoxiong Wu
Facility Name
General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yu
First Name & Middle Initial & Last Name & Degree
Li Yu
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou
First Name & Middle Initial & Last Name & Degree
Daobin Zhou
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanyun Ren
First Name & Middle Initial & Last Name & Degree
Hanyun Ren
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke

12. IPD Sharing Statement

Learn more about this trial

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

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