Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Peking University
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University
ClinicalTrials.gov Identifier:
NCT01765231
First received: January 9, 2013
Last updated: January 21, 2015
Last verified: January 2015

January 9, 2013
January 21, 2015
January 2013
December 2015   (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 ]
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 anti-tumor therapy ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01765231 on ClinicalTrials.gov Archive Site
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 ]
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 anti-tumor therapy ] [ Designated as safety issue: Yes ]
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.
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.
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: Observation arm
    Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
    Other Name: Therapeutic entecavir group
  • 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: Observation arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
December 2016
December 2015   (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   (Adult, Senior)
No
Contact: Jun Zhu zj@bjcancer.org
Contact: Yuqin Song songyuqin622@sina.com
China
 
NCT01765231
PKU-2012111305
Yes
Not Provided
Not Provided
Jun Zhu, Peking University
Peking University
Not Provided
Principal Investigator: Jun Zhu Peking University Cancer Hospital & Institute
Peking University
January 2015

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