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

Launched by YONSEI UNIVERSITY · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two medications, Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF), to see if TAF is just as effective and safe for preventing Hepatitis B in patients with blood cancers. Patients who are getting ready for treatments like chemotherapy or stem cell transplants may need this antiviral treatment to protect their liver from Hepatitis B. The trial aims to confirm that TAF can safely suppress the virus without causing harm to the kidneys or bones, which are concerns with some antiviral medications.

To be eligible for this study, you must be an adult between 19 and 64 years old, have a positive Hepatitis B test, and be scheduled for specific cancer treatments. However, if you are already taking antiviral medications for Hepatitis B, have certain health issues, or are pregnant or breastfeeding, you may not qualify. If you decide to participate, you will need to sign a consent form, and you can expect to be monitored closely for any side effects from the medication. This trial is important for ensuring that patients with blood cancers have safe and effective options to prevent Hepatitis B during their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult men and women over 19 years of age and under 65 years of age
• • 2. 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
• • 3. HBcAb positive patient
• • 4. Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form
• Exclusion Criteria:
• • 1. Patients taking oral chronic hepatitis B antiviral drugs before starting the study
• • 2. Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption
• • 3. Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate
• • 4. Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis
• • 5. Hepatitis C patients
• • 6. HIV-infected patients
• • 7. Pregnant women, lactating women, or patients planning to become pregnant
• • 8. If you are participating in another clinical trial administering medication
• • 9. Patients who do not agree to participate in this clinical trial
• • 10. Adults with impaired consent capacity who are unable to give consent on their own
• • 11. Those who have taken other clinical trial drugs for less than 24 weeks
• • 12. Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.