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

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Trial Information


Inclusion Criteria:



- treatment-naive patients with B-cell lymphoma

- HBsAg positive at baseline

- treated with rituximab-based immunochemotherapy

- life expectancy of more than 3 months

Exclusion Criteria:

- younger than 18 years old

- HBsAg negative at baseline

- pregnant or lactating women

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

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-2012111304

NCT ID:

NCT01768195

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Hepatitis B
  • Lymphoma
  • Hepatitis B Virus
  • Therapeutic Uses
  • Antiviral Agents
  • rituximab
  • Hepatitis
  • Hepatitis A
  • Hepatitis B

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