S1614: A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

About this Study

The purpose of this study is to study the effect of tenofovir alafenamide in preventing liver complications in patients with current or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors.

Sponsor Protocol ID:S1416
IRB Number:2019-0277
Actively Enrolling
Interventional
Phase 3
July 12, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
  • Must be diagnosed with stage I-III solid tumor malignancy
  • Planning to receive systemic anti-cancer therapy for solid tumor
  • Must be registered to study less than or equal to 28 day prior to the planned start date of anti-cancer therapy
  • Must have tested positive for HBsAg or anti-HBc and must have baseline HBV deoxyribonucleic acid (DNA) completed less than or equal to 42 days prior to registration

Exclusion Criteria
  • Diagnosed with cancer other than current cancer within the past five years
  • Has lymphoma, leukemia or myeloma
  • Has primary liver cancer, known cirrhosis, or evidence of any cancer that involves the liver
  • Received cancer therapy regimen that includes anti-CD20
  • Receiving antiviral medications against active HBV; patients who have previously received antiviral medication must not have required any antiviral medication active against HBV greater than or equal to 90 days prior to registration to this study
  • Prior hematopoietic stem cell transplantation therapy
  • Current active hepatitis C infection
  • History orĀ  human immunodeficiency (HIV) infection
  • Pregnant or breast-feeding

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Henegan, John C, M.D.
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