Clinical Trial for Non-inferiority and Safety of Tenofovi... | NCT06221657

Studies
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

NCT06221657

Sponsor

Yonsei University

Status

Not yet recruiting

Last Update Posted

Jan 24, 2024Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication

Interventions

Vemlidy
Virreal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 15, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Jan 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2024

Last Update Posted Date

Jan 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
TAF group	Experimental		Drug: Vemlidy
TDF group	Active Comparator		Drug: Virreal

Name	Type	Description	Arm Group Labels	Other Names
Vemlidy	Drug	1 tablet once a day, oral administration	TAF group
Virreal

Measure	Description	Time Frame
Proportion of subjects maintained at HBV DNA <29 IU/mL		48 weeks

Measure	Description	Time Frame
Proportion of subjects maintaining HBV DNA <29 IU/mL		72 weeks
Proportion of subjects with serum HBV DNA <60 IU/mL		12, 24, 48, 72 weeks
Proportion of subjects maintaining HBV DNA <10 IU/mL

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult men and women over 19 years of age and under 65 years of age
Patients who meet the following criteria A or B A. Those scheduled for hematopoietic stem cell transplantation and treatment with immunosuppressants or chemotherapy.

B. Those scheduled to receive anticancer treatment including rituximab
HBcAb positive patient
Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form

Exclusion Criteria:

Patients taking oral chronic hepatitis B antiviral drugs before starting the study
Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption
Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate
Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis
Hepatitis C patients
HIV-infected patients
Pregnant women, lactating women, or patients planning to become pregnant
If you are participating in another clinical trial administering medication
Patients who do not agree to participate in this clinical trial
Adults with impaired consent capacity who are unable to give consent on their own
Those who have taken other clinical trial drugs for less than 24 weeks
Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided