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Baloxavir MarboxilWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D007251 Influenza, Human NIH 0.30

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There is one clinical trial.

Clinical Trials

1 A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

NCT03653364 Influenza Drug: Baloxavir Marboxil
MeSH:Influenza, Human

Primary Outcomes

Description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to Day 29

Secondary Outcomes

Measure: Plasma Concentrations of Baloxavir Marboxil and S-033447

Time: Day 2 and Day 4

Measure: Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Maximum Plasma Concentration (Cmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Time to Maximum Plasma Concentration (Tmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Apparent Half-Life (T1/2) of baloxavir marboxil and S-033447

Time: Up to Day 10

Description: Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours: A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale [CARIFS]) A "yes" response to the following question on the CARIFS: "Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?" First return to afebrile state (tympanic temperature ≤37.2 degree Celsius [°C])

Measure: Time to Alleviation of Influenza Signs and Symptoms

Time: Up to Day 15

Description: Length of time taken by participants to return to afebrile state [tympanic temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.

Measure: Duration of Fever

Time: Up to Day 15

Description: The efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 [no problem] or 1 [minor problem] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire).

Measure: Duration of Symptoms

Time: Up to Day 15

Measure: Time to Return to Normal Health and Activity

Time: Up to Day 15

Description: The influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.

Measure: Frequency of Influenza-Related Complications

Time: Up to Day 29

Measure: Percentage of Participants Requiring Antibiotics

Time: Up to Day 29

Measure: Time to Cessation of Viral Shedding by Virus Titer and by RT-PCR

Time: Day 1 - Day 29

Measure: Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29

Time: Baseline, Day 2, 4, 6, 10, 15, 29

Measure: Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29

Time: Day 2, 4, 6, 10, 15, 29

Measure: Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)

Time: Day 1 - Day 29

No related HPO nodes (Using clinical trials)