Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

This study is currently recruiting participants.
Verified July 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01914744
First received: March 2, 2013
Last updated: July 31, 2013
Last verified: July 2013

March 2, 2013
July 31, 2013
February 2013
December 2015   (final data collection date for primary outcome measure)
Incidence rate of HBV reactivation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Defined by increased level of HBV DNA
Same as current
Complete list of historical versions of study NCT01914744 on ClinicalTrials.gov Archive Site
  • Incidence rate of hepatitis and HBV reactivation-related hepatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Defined by increased level of alanine transaminase
  • Incidence rate and median time of treatment delay due to hepatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by information of treatment delay
  • Incidence rate and median time of HBV DNA level normalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by information of HBV DNA level normalization
Same as current
Incidence of drug resistance of viral variants [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
 
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Non-Hodgkin Lymphoma
  • Hepatitis B Reactivation
  • Drug: Entecavir
    entecavir 0.5 mg/day PO
    Other Name: baraclude
  • Drug: Lamivudine
    lamivudine 100 mg/day PO
    Other Name: epivir
  • Experimental: entecavir
    entecavir 0.5 mg/day PO
    Interventions:
    • Drug: Entecavir
    • Drug: Lamivudine
  • Active Comparator: lamivudine
    lamivudine 100 mg/day PO
    Interventions:
    • Drug: Entecavir
    • Drug: Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
82
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously untreated NHL suitable for CHOP/R-CHOP treatment
  • Age range 18-80 years old
  • HBsAg positive with high level of HBV DNA
  • Eastern Cooperative Oncology Group performance status 0-2
  • Life expectancy of more than 3 months
  • Adequate organ function

Exclusion Criteria:

  • Primary or secondary central nervous system involvement
  • With hepatitis C virus infection
  • Previous serious cardiac disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
Both
18 Years to 80 Years
No
Contact: Ye Guo, MD +86 21 64175590 ext 8906 pattrick_guo@msn.com
China
 
NCT01914744
LMTG 13-03
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Ye Guo, MD Fudan University
Fudan University
July 2013

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