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To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma

NCT02585947 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-12-21

No results posted yet for this study

Summary

The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.

Conditions

  • Non-Hodgkin's Lymphoma, Burkitt's

Interventions

DRUG

Tenofovir

Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Konkuk University Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yoon Jun Kim, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-06-30
Completion
2018-09-30

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585947 on ClinicalTrials.gov