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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/NCT02532283




Registration number
NCT02532283
Ethics application status
Date submitted
21/08/2015
Date registered
25/08/2015
Date last updated
27/03/2020

Titles & IDs
Public title
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection
Secondary ID [1] 0 0
2015-003002-17
Secondary ID [2] 0 0
CR107746
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-63623872
Treatment: Drugs - Placebo
Treatment: Drugs - Oseltamivir

Experimental: JNJ-63623872 plus Oseltamivir - Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.

Experimental: Placebo plus Oseltamivir - Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.


Treatment: Drugs: JNJ-63623872
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.

Treatment: Drugs: Placebo
Participants will be administered placebo tablets orally twice daily for 7 days.

Treatment: Drugs: Oseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Timepoint [1] 0 0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Primary outcome [2] 0 0
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Timepoint [2] 0 0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Primary outcome [3] 0 0
Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
Timepoint [3] 0 0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Secondary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Timepoint [1] 0 0
Up to 28 Days
Secondary outcome [2] 0 0
Time to Influenza A Viral Negativity
Timepoint [2] 0 0
Up to 14 Days
Secondary outcome [3] 0 0
Influenza Viral Load Over Time
Timepoint [3] 0 0
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Secondary outcome [4] 0 0
Rate of Decline in Viral Load
Timepoint [4] 0 0
Up to Day 7
Secondary outcome [5] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Timepoint [5] 0 0
Baseline up to Day 8
Secondary outcome [6] 0 0
Percentage of Participants With Influenza Complications
Timepoint [6] 0 0
Up to 28 Days
Secondary outcome [7] 0 0
Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score
Timepoint [7] 0 0
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33
Secondary outcome [8] 0 0
Time to Improvement of Vital Signs
Timepoint [8] 0 0
Up to 28 Days
Secondary outcome [9] 0 0
Time to Improvement of Respiratory Status
Timepoint [9] 0 0
Up to 28 Days
Secondary outcome [10] 0 0
Percentage of Participants With Clinical Outcome Based on Ordinal Scale
Timepoint [10] 0 0
Day 8
Secondary outcome [11] 0 0
Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir
Timepoint [11] 0 0
Up to 28 Days
Secondary outcome [12] 0 0
Time to Return to Premorbid Functional Status
Timepoint [12] 0 0
Up to Day 33
Secondary outcome [13] 0 0
Time to Hospital Discharge
Timepoint [13] 0 0
Up to 28 Days
Secondary outcome [14] 0 0
Time to Return to Usual Health
Timepoint [14] 0 0
Up to Day 33
Secondary outcome [15] 0 0
Time to Significant Reduction in FLU-PRO Influenza Symptom Severity
Timepoint [15] 0 0
Up to Day 33
Secondary outcome [16] 0 0
Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)
Timepoint [16] 0 0
Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33

Eligibility
Key inclusion criteria
- Participant requires hospitalization to treat influenza infection and/or to treat
complications of influenza infection

- Participant tested positive for influenza A infection within 1 day of signing of the
informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based
rapid molecular diagnostic assay

- Participants must be capable of swallowing study medication tablets and capsules

- Each participant (or their legally acceptable representative) must sign an ICF
indicating that he or she understands the purpose of and procedures required for the
study and is willing to participate in the study

- Participant must be willing and able to adhere to the prohibitions and restrictions
specified in the protocol
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant received more than 3 doses of the influenza antiviral medication
oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or
ribavirin within 6 months prior to Screening

- Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any
physical abnormality which limits the ability to collect regular nasal specimens

- Participant is immunocompromised, whether due to underlying medical condition
(example, malignancy) or medical therapy (example, medications, chemotherapy,
radiation, post-transplant)

- Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration

- Participant has an estimated glomerular filtration rate (eGFR) less than or equal to
(<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification
of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most
recent clinically relevant creatinine value if available

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 2
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
11/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2017
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- South Brisbane
Recruitment hospital [3] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belgium
State/province [10] 0 0
Aalst
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Brazil
State/province [13] 0 0
Passo Fundo
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
Grenoble
Country [20] 0 0
France
State/province [20] 0 0
Limoges
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Nantes
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Poitiers
Country [25] 0 0
France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Saint-Priest en Jarez
Country [27] 0 0
France
State/province [27] 0 0
Tours Cedex 9
Country [28] 0 0
Germany
State/province [28] 0 0
Donaustauf
Country [29] 0 0
Germany
State/province [29] 0 0
Jena
Country [30] 0 0
Hong Kong
State/province [30] 0 0
Hong Kong
Country [31] 0 0
Malaysia
State/province [31] 0 0
Kota Bharu
Country [32] 0 0
Malaysia
State/province [32] 0 0
Kuala Lumpur
Country [33] 0 0
Malaysia
State/province [33] 0 0
Kuala
Country [34] 0 0
Malaysia
State/province [34] 0 0
Kuching
Country [35] 0 0
Malaysia
State/province [35] 0 0
Melaka
Country [36] 0 0
Malaysia
State/province [36] 0 0
Miri
Country [37] 0 0
Malaysia
State/province [37] 0 0
Sungai Buloh
Country [38] 0 0
Malaysia
State/province [38] 0 0
Taiping
Country [39] 0 0
Netherlands
State/province [39] 0 0
Rotterdam
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
Netherlands
State/province [41] 0 0
Zutphen
Country [42] 0 0
New Zealand
State/province [42] 0 0
Hamilton
Country [43] 0 0
Singapore
State/province [43] 0 0
Singapore
Country [44] 0 0
Spain
State/province [44] 0 0
Alicante
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Bizkaia
Country [47] 0 0
Spain
State/province [47] 0 0
Elche
Country [48] 0 0
Spain
State/province [48] 0 0
Granada
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Mataró
Country [51] 0 0
Spain
State/province [51] 0 0
San Sebastián
Country [52] 0 0
Spain
State/province [52] 0 0
Vigo
Country [53] 0 0
Sweden
State/province [53] 0 0
Malmö
Country [54] 0 0
Sweden
State/province [54] 0 0
Umeå
Country [55] 0 0
Sweden
State/province [55] 0 0
Uppsala
Country [56] 0 0
Turkey
State/province [56] 0 0
Ankara
Country [57] 0 0
Turkey
State/province [57] 0 0
Eskisehir
Country [58] 0 0
Turkey
State/province [58] 0 0
Istanbul
Country [59] 0 0
Turkey
State/province [59] 0 0
Izmir
Country [60] 0 0
Turkey
State/province [60] 0 0
Trabzon

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 Pharmacokinetic parameters of JNJ-63623872 in
combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to
adults (aged 18 to <= 64 years) with influenza A infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02532283
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