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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 2013 by Peking University
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University
ClinicalTrials.gov Identifier:
NCT01765231
First received: January 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 9, 2013
January 9, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
  • 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
  • Drug: Therapeutic entecavir
    Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
  • 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.
    Intervention: Drug: Entecavir prophylaxis
  • Active Comparator: Observation arm
    Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
    Intervention: Drug: Therapeutic entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jun Zhu zj@bjcancer.org
Contact: Yuqin Song songyuqin622@sina.com
China
 
NCT01765231
PKU-2012111305
Not Provided
Jun Zhu, Peking University
Peking University
Not Provided
Principal Investigator: Jun Zhu Peking University Cancer Hospital & Institute
Peking University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP