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

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Fudan University

Status and phase

Unknown
Phase 2

Conditions

Hepatitis B Reactivation
Non-Hodgkin Lymphoma

Treatments

Drug: Entecavir
Drug: Lamivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT01914744
LMTG 13-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

entecavir
Experimental group
Description:
entecavir 0.5 mg/day PO
Treatment:
Drug: Lamivudine
Drug: Entecavir
lamivudine
Active Comparator group
Description:
lamivudine 100 mg/day PO
Treatment:
Drug: Lamivudine
Drug: Entecavir

Trial contacts and locations

1

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Central trial contact

Ye Guo, MD

Data sourced from clinicaltrials.gov

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