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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03381196




Registration number
NCT03381196
Ethics application status
Date submitted
18/12/2017
Date registered
21/12/2017
Date last updated
24/05/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
Secondary ID [1] 0 0
2017-002217-59
Secondary ID [2] 0 0
CR108400
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Pimodivir 600 mg
Treatment: Drugs - Placebo
Other interventions - SOC Treatment

Experimental: Treatment Arm 1 (pimodivir + SOC treatment) - Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).

Placebo Comparator: Treatment Arm 2 (placebo + SOC treatment) - Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.


Treatment: Drugs: Pimodivir 600 mg
Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6).

Treatment: Drugs: Placebo
Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6).

Other interventions: SOC Treatment
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [1] 0 0
Number of Participants Hospitalized After Treatment Initiation
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Viral Load Over Time
Timepoint [2] 0 0
Baseline, Day 3, 6, 10, 14
Secondary outcome [3] 0 0
Number of Participants With Emergence of Viral Resistance to Pimodivir
Timepoint [3] 0 0
Up to Day 28
Secondary outcome [4] 0 0
Plasma Concentration of Pimodivir
Timepoint [4] 0 0
Day 3, 6, 7
Secondary outcome [5] 0 0
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Timepoint [5] 0 0
Up to Day 28
Secondary outcome [6] 0 0
Number of Participants With Clinically Significant Changes in Laboratory Tests
Timepoint [6] 0 0
Up to Day 28
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Timepoint [7] 0 0
Up to Day 28
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [8] 0 0
Up to Day 28

Eligibility
Key inclusion criteria
- Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and
have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at
least "moderate" if the symptom did not pre-exist before influenza onset, or scored
worse than usual if the symptom pre-existed as determined by subject's ratings on
Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device.
Symptoms must include the following by category: a) Respiratory symptoms: cough, sore
throat, nasal congestion b) Systemic symptoms: headache, body aches or pain,
feverishness, fatigue

- Tested positive for influenza A infection after the onset of symptoms, using a rapid
influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction
(PCR)-based or other rapid molecular diagnostic assay

- Not be in need of hospitalized medical care at screening. Emergency room or hospital
observation status for an anticipated duration of less than (<)24 hours is not
considered hospitalization as long as a determination of the need for hospitalization
has not been made

- Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours
after onset of influenza symptoms

- Participants 13 to 65 years of age, inclusive must also have at least 1 of the
following: a) Cardiovascular or cerebrovascular disease (including congenital heart
disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated
hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung
disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or
medication (for example, participants with human immunodeficiency virus [HIV], cancer,
or chronic liver or kidney disease [presence of kidney damage for >3 months, defined
by structural or functional abnormalities of the kidney, with or without decreased GFR
manifested by: pathological abnormalities; OR markers of kidney damage, including
abnormalities in the composition of the blood or urine or abnormalities in imaging
tests], or participants taking chronic systemic steroids)
Minimum age
13 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received more than (>)1 dose of influenza antiviral medication (for example,
oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to
first study drug intake, or received intravenous (IV) peramivir >1 day prior to
screening

- Unstable angina pectoris or myocardial infarction within 30 days prior to screening
(inclusive)

- Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial
arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de
Pointes syndrome

- Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C
infection undergoing hepatitis C antiviral therapy

- Severely immunocompromised in the opinion of the investigator (for example, known
cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter
[cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy
completed within 2 weeks prior to screening, history of stem cell transplant within 1
year prior to screening, history of a lung transplant)

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2020
Sample size
Target
Accrual to date
Final
553
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Pune
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Israel
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Safed
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Seoul
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Stavropol
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Russian Federation
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Yaroslavl
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Slovakia
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Kosice
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Slovakia
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Michalovce
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Slovakia
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Slovakia
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Svidnik
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Brandfort
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Breyten
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Cape Town
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Chatsworth
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in
combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC
treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03381196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03381196