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New treatment option for Hematopoietic and Lymphoid Cell Neoplasm
Official title Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
ClinicalTrials.gov ID: NCT04712539
What this study is testing
What is Baloxavir Marboxil?
Baloxavir Marboxil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as BXM, Xofluza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Hematopoeitic cell transplant recipients OR hematological malignancy patients
- Diagnosed with influenza ⱡ
- Evidence of LRTI\ or high risk upper respiratory tract infection (URTI)\ \ ⱡ A positive multiplex PCR for influenza is required to confirm a...
You likely can't join if
- Patient requires mechanical ventilation at time of enrollment
- Patient is younger than the age of 12 years old
- The patient is unable to tolerate oral therapy
- The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
- The patient is on a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as...
- The patient is unable to consent will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.