Influenza, HumanPhase 3PearlstoneNCT07827599
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
A Phase 3 study testing Baloxavir marboxil in people with Influenza, Human and Respiratory Tract Infections, run by Hoffmann-La Roche at 8 sites in China.
Trial summary
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
- What is being tested?
- Baloxavir marboxil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 8 sitesChina
- Study dates
- 16 Oct 2026to 30 Apr 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Index Participants (Participants With Influenza Virus Infection):
- First participant in a household with influenza virus infection in the current influenza season
- Fewer than 6 HHCs
- Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study
- Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result
- Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form
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- PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test
- HHCs of Index Participants:
- Lived with the index participant for 48 hours or more prior to informed consent/assent
- Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) <37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza
- For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary
- PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test
Who cannot join
- HHCs of Index Participants:
- Diagnosed with influenza during the current influenza season
- Unable to live with the index patient from screening until Day 10
- Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening
- Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season
- Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents
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- Immunocompromised
- Use of any medications with anti-influenza effect within 30 days prior to screening
- Known allergy and/or history of significant intolerance against baloxavir marboxil
- Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer
- Note: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https://forpatients.roche.com/ contact
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry contact
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
The First People's Hospital of Changde
Changde, DUMMY_VALUE
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280
- Recruiting
Huizhou Central People's Hospital
Huizhou, 516001
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
- Recruiting
Ningbo No.2 Hospital
Ningbo, 315000
- Recruiting
Sanmenxia Central Hospital
Sanmenxia, DUMMY_VALUE
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
- Recruiting
Xiamen Maternal and Child Health Hospital
Xiamen, 361001
About this study
Official title: A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).
- Being tested
- Baloxavir marboxil, Placebo
- Keywords
- Influenza, Baloxavir Marboxil, Household Contacts
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir marboxilDrug
Also called Xofluza; RO7191686
Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.
PlaceboDrug
Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Baloxavir Marboxil | Experimental | HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol. Receives: Drug: Baloxavir marboxil |
| Placebo | Placebo comparator | HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol. Receives: Drug: Placebo |
| No Intervention | No intervention | Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom
Measured: From Day 1 up to Day 10
Secondary outcomes (3)
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)
Measured: From Day 1 up to Day 10
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms
Measured: From Day 1 up to Day 10
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start16 Oct 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827599
- Sponsor's protocol ID
- YV46459
- Acronym
- Pearlstone
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.