Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-29 @ 11:54 PM
Study NCT ID:
NCT06221657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2024-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: