A Phase 3 interventional study of Baloxavir Marboxil in Influenza, sponsored by Hoffmann-La Roche. Recruiting at 51 sites in 4 countries. Open to participants aged 3 Weeks to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
Among 18 studies testing baloxavir in Influenza, Human — 7 open to participants now, 7 under way, 5 of them phase 3. baloxavir · Influenza, Human.
Among the 18 studies testing baloxavir in Influenza, Human, this one is the 6th largest by planned enrollment, is one of 3 that started in 2023, is one of 12 in phase 3, and was the 12th registered.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →7 of the 18 studies testing baloxavir in Influenza, Human are open now, in 12 countries. Each count lists the studies.
baloxavir: first FDA approval 2018 (XOFLUZA), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 119 Influenza, Human studies recruiting now, 62 (52%) set no upper age limit and 47 (39%) stop at 75 or younger; 31 take children under 18; 65 take healthy volunteers.
This study: 3 Weeks to 11 Years · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2023.
Median enrollment 483 across the 18 interventional studies. Of the 10 that completed or were terminated, 8 (80%) have results posted.
9 of 18 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
20 studies in Influenza, Human by Hoffmann-La Roche: 2 open now, 2 under way, 2 of them phase 3. Of 18 finished, 14 (78%) have results posted.
Among the 20 studies in Influenza, Human by Hoffmann-La Roche, this one is the 2nd largest by planned enrollment of the 17 interventional ones, is the only one that started in 2023, is one of 10 in phase 3, and was the 18th registered.
Hoffmann-La Roche’s Influenza, Human studies by the year they started, since 2006.
5 of the studies testing baloxavir in Influenza, Human that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07314905Phase 3Unity Health TorontoAdaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) | 2027-03-31 |
| NCT06653569Phase 3Dre Pauline VetterEfficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment) | 2027-04 |
| NCT07827599Phase 3Hoffmann-La RocheA Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants | 2027-04-30 |
| NCT06094010Phase 3Hoffmann-La RocheA Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts | 2027-05-11 |
| NCT05648448University of OxfordA Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza | 2027-01-01 |
Among the 18 studies testing baloxavir in Influenza, Human, from their registry updates:
Among Hoffmann-La Roche’s 20 in Influenza, Human:
This study consists of two parts: Part A Surveillance and Part B Transmission.
The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \<12 years with influenza treated with baloxavir marboxil.
Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.
Inclusion Criteria (Part A):
Inclusion Criteria (Part B):
[A] IP:
[B] HHCs:
- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility
[C] Partial HHC:
[D] Full-study HHC:
Exclusion Criteria (Part A):
Exclusion Criteria (Part B):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment.
Drug: Baloxavir Marboxil
Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms \[kg\]: 80 milligrams \[mg\]; ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 milligrams per kilogram \[mg/kg\]).
Also known as: XOFLUZA®; RO7191686
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
Time frame: Day 1 (At Baseline)
Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years)
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)
Time frame: Day 1 (At Baseline)
Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Time frame: At Baseline (Day 1); Days 4, 6 and 10
Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions
Time frame: Days 4, 6 and 10
Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Time frame: Up to Day 29
Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP
Time frame: Day 6, Day 10
Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP
Time frame: Day 6, Day 10
Percentage of HHCs Who Become PCR (+) for Influenza Bearing a PA/I38X Substitution (or Other Identified Substitution) Including All Data up to Day 15
Time frame: Up to Day 15
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for May 2027, 41 months after the start.
Of 118 industry-sponsored phase 3 interventional studies under Influenza, Human, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 41 months is above that.
Counting every sponsor, half of 153 studies reached it within 8 months; a quarter within 4 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Baloxavir