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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Hepatitis B

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis

Outcome Time Frame:

from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy

Safety Issue:

Yes

Principal Investigator

Jun Zhu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University Cancer Hospital & Institute

Authority:

China: Ethics Committee

Study ID:

PKU-2012111305

NCT ID:

NCT01765231

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Hepatitis B
  • Lymphoma
  • Hepatitis B virus
  • Therapeutic Uses
  • Antiviral Agents
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Lymphoma

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