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NOT YET RECRUITING
NCT06221657
PHASE4

Clinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of Tenofovir alafenamide (TAF) compared to Tenofovir disoproxil fumarate (TDF) in patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment. Confirm. In the case of TAF, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to TDF during the first administration of TAF to patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment was investigated. We aim to secure non-inferiority and additionally confirm the safety of TAF's known advantages of reducing renal function damage and protecting bone function.

Official title: A Single-center, Prospective, Randomized, Open-label, Comparative, Investigator-initiated Clinical Trial to Confirm the Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-02-01

Completion Date

2026-12-31

Last Updated

2024-01-24

Healthy Volunteers

No

Interventions

DRUG

Vemlidy

1 tablet once a day, oral administration

DRUG

Virreal

1 tablet once a day, oral administration