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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02949011




Registration number
NCT02949011
Ethics application status
Date submitted
27/10/2016
Date registered
27/10/2016
Date last updated
1/05/2018

Titles & IDs
Public title
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications
Secondary ID [1] 0 0
2016-002688-32
Secondary ID [2] 0 0
1602T0832
Universal Trial Number (UTN)
Trial acronym
CAPSTONE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baloxavir Marboxil
Treatment: Drugs - Placebo to Baloxavir Marboxil
Treatment: Drugs - Oseltamivir
Treatment: Drugs - Placebo to Oseltamivir

Experimental: Baloxavir Marboxil - Participants aged = 12 years will receive two or four 20-mg S 033188 tablets orally on Day 1 and one oseltamivir placebo capsule orally twice a day (BID) on Days 1 to 5.

Active Comparator: Oseltamivir - Participants aged = 12 years will receive 75 mg oseltamivir twice a day on Days 1 to 5 and two or four S 033188 placebo tablets on Day 1.

Placebo Comparator: Placebo - Participants aged = 12 years will receive two or four S 033188 placebo tablets on Day 1 and one oseltamivir placebo capsule orally twice a day on Days 1 to 5.


Treatment: Drugs: Baloxavir Marboxil
2-4 X 20-mg tablets taken orally

Treatment: Drugs: Placebo to Baloxavir Marboxil
2-4 X 20-mg tablets taken orally

Treatment: Drugs: Oseltamivir
75-mg capsules taken orally

Treatment: Drugs: Placebo to Oseltamivir
Placebo capsules matching oseltamivir 75-mg capsules

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to improvement of symptoms - Time to improvement of symptoms is defined as the time from initiation of study treatment to improvement of influenza symptoms for at least 24 hours.
Timepoint [1] 0 0
From Day 1 pretreatment up to Day 14
Secondary outcome [1] 0 0
Percentage of participants positive for influenza virus titer and viral RNA at each time point - Defined as the percentage of patients whose virus titer and ribonucleic acid (RNA) load are greater than the lower limit of quantification among those assessed for virus titer and RNA load. RNA load is measured by reverse transcription polymerase chain reaction (RT-PCR).
Timepoint [1] 0 0
Days 1, 2, 3, 5 and 9
Secondary outcome [2] 0 0
Change from baseline in virus titer at each time point
Timepoint [2] 0 0
From Day 1 pretreatment to Days 2, 3, 5, and 9
Secondary outcome [3] 0 0
Change from Baseline in viral RNA load at each time point
Timepoint [3] 0 0
From Day 1 pretreatment to Days 2, 3, 5, and 9
Secondary outcome [4] 0 0
Area under the curve (AUC) adjusted by baseline in virus titer - Defined as AUC of change from baseline in virus titer. The AUC is calculated using the trapezoidal method.
Timepoint [4] 0 0
Day 1 to Day 9
Secondary outcome [5] 0 0
Area under the curve (AUC) adjusted by baseline in viral RNA load - Defined as AUC of change from baseline in viral RNA load. The AUC is calculated using the trapezoidal method.
Timepoint [5] 0 0
Day 1 to Day 9
Secondary outcome [6] 0 0
Time to cessation of viral shedding - Defined as the time between the initiation of the study treatment and first time when the virus titer/RT-PCR is less than the lower limit of quantification
Timepoint [6] 0 0
From Day 1 to Day 9
Secondary outcome [7] 0 0
Percentage of participants whose symptoms have been improved at each time point
Timepoint [7] 0 0
Days 2-9, morning and evening, and days 10-14, evenings
Secondary outcome [8] 0 0
Time to alleviation of symptoms - Time to alleviation of symptoms is defined as the time between the initiation of the study treatment and the alleviation of influenza symptoms. The alleviation of influenza symptoms is defined as the time when all of 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) have been assessed by the patient.
Timepoint [8] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [9] 0 0
Time to improvement in the 4 systemic symptoms - Defined as the time between the initiation of the study treatment and the improvement in the 4 systemic symptoms symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue).
Timepoint [9] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [10] 0 0
Time to improvement in the 3 respiratory symptoms - Defined as the time between the initiation of the study treatment and the improvement in the 3 respiratory symptoms (cough, sore throat, and nasal congestion).
Timepoint [10] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [11] 0 0
Time to resolution of fever - Defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever is defined as the time when the patient's self-measured temperature becomes less than 37ºC.
Timepoint [11] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [12] 0 0
Percentage of participants reporting normal temperature at each time point - Defined as the percentage of patients whose self-measured temperature drops to less than 37ºC after the initiation of the study treatment.
Timepoint [12] 0 0
Days 1 to 3 at morning, noon, evening and bedtime, Days 4 to 14 morning and evening
Secondary outcome [13] 0 0
Body temperature at each time point
Timepoint [13] 0 0
Days 1 to 3 at morning, noon, evening and bedtime, Days 4 to 14 morning and evening
Secondary outcome [14] 0 0
Time to improvement of each influenza symptom - Defined as the time between the initiation of the study treatment and the alleviation of each influenza symptom.
Timepoint [14] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [15] 0 0
Time to return to preinfluenza health status - Patients will be asked to record their preinfluenza health status (for someone your age and your health condition). Return to preinfluenza health status is defined as time from the initiation of the study treatment to time to return to preinfluenza health status.
Timepoint [15] 0 0
Day 1 pretreatment up to Day 14
Secondary outcome [16] 0 0
Percentage of participants requiring systemic antibiotics for infections secondary to influenza infection
Timepoint [16] 0 0
Day 2 to Day 22
Secondary outcome [17] 0 0
Percentage of participants with influenza-related complications - Defined as the percentage of patients who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia) as an adverse event after the initiation of study treatment.
Timepoint [17] 0 0
Day 1 to Day 22
Secondary outcome [18] 0 0
Number of participants with adverse events - The frequency of AEs in patients with influenza after Baloxavir Marboxil, after oseltamivir, and after placebo.
Timepoint [18] 0 0
Day 1 to Day 22 plus or minus 3 days

Eligibility
Key inclusion criteria
1. Patients or their legal guardians who provide written informed consent to participate
in the study on a voluntary basis. For adolescent patients, informed consent/assent of
voluntary participation should be obtained in accordance with local requirements.

2. Male or female patients = 12 years at the time of signing the informed consent/assent
form.

3. Patients with a diagnosis of influenza confirmed by all of the following:

1. Fever = 38ºC (axillary) during the predose examinations or within the 4 hours
prior if antipyretics were taken

2. A positive rapid influenza diagnostic test (RIDT) result OR A patient with a
negative RIDT may be enrolled if the patient reports contact with a known case of
influenza within the prior 7 days and all other inclusion criteria are met.

3. At least 1 each of the following general and respiratory symptoms associated with
influenza is present with a severity of moderate or greater:

i. General symptoms (headache, feverishness or chills, muscle or joint pain, or
fatigue) ii. Respiratory symptoms (cough, sore throat, or nasal congestion)

4. The time interval between the onset of symptoms and the predose examinations is 48
hours or less. The onset of symptoms is defined as either:

1. Time of the first increase in body temperature (an increase of at least 1ºC from
normal body temperature)

2. Time when the patient experiences at least 1 new general or respiratory symptom

5. If a women of childbearing potential, agrees to use a highly effective method of
contraception for 3 months after the first dose of study drug

6. Patients will be considered at high risk* of influenza complications due to the
presence of at least 1 of the following inclusion criteria:

1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or
cystic fibrosis)

2. Endocrine disorders (including diabetes mellitus)

3. Residents of long-term care facilities (eg, nursing homes)

4. Compromised immune system (including patients receiving corticosteroids not
exceeding 20 mg of prednisolone or equivalent, and patients being treated for
human immunodeficiency virus [HIV] infection with a CD4 count > 350 cells/mm³
within the last 6 months)

5. Neurological and neurodevelopmental disorders (including disorders of the brain,
spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure
disorders], stroke, muscular dystrophy, or spinal cord injury)

6. Heart disease (such as congenital heart disease, congestive heart failure, or
coronary artery disease), excluding hypertension without any other heart-related
symptoms

7. Adults aged = 65 years

8. American Indians and Alaskan Natives

9. Blood disorders (such as sickle cell disease)

10. Metabolic disorders (such as inherited metabolic disorders and mitochondrial
disorders)

11. Morbid obesity (body mass index = 40 kg/m²)

12. Women who are within 2 weeks postpartum and are not breastfeeding
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with severe influenza virus infection requiring inpatient treatment.

2. Patients with known allergy to oseltamivir (Tamiflu®).

3. Patients unable to swallow tablets or capsules.

4. Patients who have previously received Baloxavir Marboxil.

5. Patients weighing = 40 kg.

6. Patients who have been exposed to an investigational drug within 30 days prior to the
predose examinations.

7. Women who are pregnant, breastfeeding, or have a positive pregnancy test at the
predose examinations. The following female patients who have documentation of either a
or b below do not need to undergo a pregnancy test at the predose examinations:

1. Postmenopausal women (defined as cessation of regular menstrual periods for 2
years or more and confirmed by a follicle-stimulating hormone test)

2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or
tubal ligation

8. Patients with concurrent infections at the predose examinations requiring systemic
antimicrobial therapy.

9. Patients with liver disease associated with hepatic impairment.

10. Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).

11. Patients with untreated HIV infection or treated HIV infection with a CD4 count below
350 cells/mm3 in the last 6 months.

12. Patients with immunosuppression following organ or bone marrow transplants.

13. Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic
corticosteroids.

14. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir,
rimantadine, umifenovir or amantadine within 30 days prior to the predose
examinations.

15. Patients who have received an investigational monoclonal antibody for a viral disease
in the last year.

16. Patients with known creatinine clearance = 60 mL/min.

17. Patients who, in the opinion of the investigator, would be unlikely to comply with
required study visits, self-assessments, and interventions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Shionogi Research Site - Bruce
Recruitment hospital [2] 0 0
Shionogi Research Site - Bathurst
Recruitment hospital [3] 0 0
Shionogi Research Site - Blacktown
Recruitment hospital [4] 0 0
Shionogi Research Site - Forbes
Recruitment hospital [5] 0 0
Shionogi Research Site - Kanwal
Recruitment hospital [6] 0 0
Shionogi Research Site - Tumbi Umbi
Recruitment hospital [7] 0 0
Shionogi Research Site - Wamberal
Recruitment hospital [8] 0 0
Shionogi Research Site - Kippa Ring
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2795 - Bathurst
Recruitment postcode(s) [3] 0 0
2148 - Blacktown
Recruitment postcode(s) [4] 0 0
2871 - Forbes
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
2261 - Tumbi Umbi
Recruitment postcode(s) [7] 0 0
2260 - Wamberal
Recruitment postcode(s) [8] 0 0
2260 - Kippa Ring
Recruitment outside Australia
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Ruse
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Hessen
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Aichi
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Chiba
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MIE
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Oita
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Shiga
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Kyoto
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Okayama
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Korea, Republic of
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Chungcheongnam-do
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Saldus
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Auckland
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Hamilton
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Diliman
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Slaskie
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Poland
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Katowice
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Romania
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Lubuskie
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Romania
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Timis
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Romania
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Bucuresti
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Romania
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Iasi
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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South Africa
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Limpopo
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South Africa
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Mpumalanga
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South Africa
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North West
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Gerona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Granada
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Spain
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Murcia
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Spain
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Tarragona
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Spain
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Zaragoza
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Taiwan
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Ilan
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Taiwan
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Taichung CITY
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Taiwan
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Taipei CITY
Country [141] 0 0
Taiwan
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Taipei
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Taiwan
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Kaohsiung City
Country [143] 0 0
Taiwan
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Taichung
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Taiwan
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Tainan City
Country [145] 0 0
Taiwan
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Tainan
Country [146] 0 0
Taiwan
State/province [146] 0 0
Taipei City
Country [147] 0 0
United Kingdom
State/province [147] 0 0
England
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Northern Ireland
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shionogi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the efficacy of a single, oral dose of
Baloxavir Marboxil compared with placebo by measuring the time to improvement of influenza
symptoms in patients with influenza presenting within 48 hours of symptom onset.
Trial website
https://clinicaltrials.gov/show/NCT02949011
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Summary results
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