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

This study is currently recruiting participants.
Verified January 2017 by Jun Zhu, Peking University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765231
First Posted: January 10, 2013
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun Zhu, Peking University
  Purpose
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.

Condition Intervention Phase
Hepatitis B Drug: Entecavir prophylaxis Drug: Observation arm Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Resource links provided by NLM:


Further study details as provided by Jun Zhu, Peking University:

Primary Outcome Measures:
  • 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 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 [ Time Frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy ]

Estimated Enrollment: 190
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Therapeutic entecavir group

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765231


Contacts
Contact: Jun Zhu zj@bjcancer.org
Contact: Yuqin Song songyuqin622@sina.com

Locations
China, Beijing
Peking University Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhu       zj@bjcancer.org   
Contact: Yuqin Song       songyuqin622@sina.com   
Sub-Investigator: Yuqin Song         
307 Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Weijing Zhang         
Principal Investigator: Weijing Zhang         
309 Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Liping Ye         
Principal Investigator: Liping Ye         
Aerospace Central Hospital Recruiting
Beijing, Beijing, China
Contact: Jingbo Wang         
Principal Investigator: Jingbo Wang         
Air Force General Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Mei Xue         
Principal Investigator: Mei Xue         
Beijing Hospital Recruiting
Beijing, Beijing, China
Contact: Hui Liu         
Principal Investigator: Hui Liu         
Cancer Institute & Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Yuankai Shi         
Principal Investigator: Yuankai Shi         
First Hospital affiliated to General Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Xiaoxiong Wu         
Principal Investigator: Xiaoxiong Wu         
General Hospital of Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Li Yu         
Principal Investigator: Li Yu         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Daobin Zhou         
Principal Investigator: Daobin Zhou         
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: Hanyun Ren         
Principal Investigator: Hanyun Ren         
Peking University People's Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaojun Huang         
Principal Investigator: Xiaojun Huang         
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaoyan Ke         
Principal Investigator: Xiaoyan Ke         
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Jun Zhu Peking University Cancer Hospital & Institute
  More Information

Responsible Party: Jun Zhu, Peking University Cancer Hospital & Institute, Peking University
ClinicalTrials.gov Identifier: NCT01765231     History of Changes
Other Study ID Numbers: PKU-2012111305
First Submitted: January 9, 2013
First Posted: January 10, 2013
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Jun Zhu, Peking University:
Lymphoma
Hepatitis B virus
Therapeutic Uses
Antiviral Agents

Additional relevant MeSH terms:
Lymphoma
Hepatitis
Hepatitis A
Hepatitis B
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents