Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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
Query!
Secondary ID [1]
0
0
2015-003002-17
Query!
Secondary ID [2]
0
0
CR107746
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Influenza A Virus
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Query!
Assessment method [1]
0
0
Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).
Query!
Timepoint [1]
0
0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Query!
Primary outcome [2]
0
0
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Query!
Assessment method [2]
0
0
Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
Query!
Timepoint [2]
0
0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Query!
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
Query!
Assessment method [3]
0
0
AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
Query!
Timepoint [3]
0
0
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Query!
Secondary outcome [1]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Query!
Assessment method [1]
0
0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Query!
Timepoint [1]
0
0
Up to 28 Days
Query!
Secondary outcome [2]
0
0
Time to Influenza A Viral Negativity
Query!
Assessment method [2]
0
0
Time to influenza A viral negativity was determined based on quantitative reverse transcription polymerase chain reaction (qRT-PCR). A participant was considered influenza A viral negative at the time point that the first negative nasal midturbinate (MT) swab was recorded (in days). Viral Load Limit of detection (LOD) = 2.18 log10 viral particles per milliliter (vp/mL). Results less than (\<) limit of quantification (LOQ) and greater than (\>) LOD (target detected) are imputed with 2.12 log10 vp/mL, results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Query!
Timepoint [2]
0
0
Up to 14 Days
Query!
Secondary outcome [3]
0
0
Influenza Viral Load Over Time
Query!
Assessment method [3]
0
0
Influenza viral load over time (Log 10 viral particles per milliliter \[vp/mL\]) was measured by qRT-PCR. Viral Load LOD = 2.18 log10 vp/mL. Results \< LOQ and \> LOD (target detected) are imputed with 2.12 log10 vp/mL and results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Query!
Timepoint [3]
0
0
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Query!
Secondary outcome [4]
0
0
Rate of Decline in Viral Load
Query!
Assessment method [4]
0
0
Rate of decline in viral load (Log10 viral particles per milliliter per day \[log10 vp/mL/day\]) during treatment was measured by qRT-PCR. Viral Load Limit of quantification (LOQ) = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \< LOQ and greater than \> LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Query!
Timepoint [4]
0
0
Up to Day 7
Query!
Secondary outcome [5]
0
0
Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Query!
Assessment method [5]
0
0
Viral load AUC was determined by qRT-PCR assay of nasal swabs. Viral Load LOQ = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \<LOQ and \>LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Query!
Timepoint [5]
0
0
Baseline up to Day 8
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Influenza Complications
Query!
Assessment method [6]
0
0
Percentage of participants with following Influenza Complications: bacterial pneumonia (culture confirmed where possible), bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease \[COPD\]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure \[CHF\], arrhythmia, stroke) and all complications were reported.
Query!
Timepoint [6]
0
0
Up to 28 Days
Query!
Secondary outcome [7]
0
0
Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score
Query!
Assessment method [7]
0
0
FLU-PRO assesses 32 influenza symptoms in each of the following body areas (domains): Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal and Body/Systemic . Participants rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 ("Not at all"), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), and 4 ("Very much"). For 5 items, severity is assessed in terms of numerical frequency, that is (i.e), vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 ("Never") to 4 ("Always").The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms).
Query!
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
Query!
Secondary outcome [8]
0
0
Time to Improvement of Vital Signs
Query!
Assessment method [8]
0
0
Time to improvement of vital signs was defined as the time from first study treatment to when at least 4 of 5 symptoms (temperature, blood oxygen saturation, heart rate, systolic blood pressure, and respiration rate) had recovered, including normalization of temperature and blood oxygen saturation. Resolution criteria for vital signs: for Temperature: oral temperature less than or equal to (\<=) 36.5 degree Celsius (C) for elderly and \<=37.2 C for adults; for oxygen saturation: greater than or equal to (\>=) 92 percent (%) on room air without supplemental oxygen; for respiratory rate: \<= 24 per minutes; for heart rate: \<= 100 per minutes and for systolic blood pressure: \>= 90 millimeters of mercury (mmHg).
Query!
Timepoint [8]
0
0
Up to 28 Days
Query!
Secondary outcome [9]
0
0
Time to Improvement of Respiratory Status
Query!
Assessment method [9]
0
0
The time to improvement of respiratory status was defined as the time from first study treatment until the first assessment of a successive series of 3 recording where normalization of blood oxygen saturation and respiration rate occurred at respiration rate \<=24 per minutes).
Query!
Timepoint [9]
0
0
Up to 28 Days
Query!
Secondary outcome [10]
0
0
Percentage of Participants With Clinical Outcome Based on Ordinal Scale
Query!
Assessment method [10]
0
0
The ordinal scale was used to assess participant's clinical outcome. It consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to intensive care unit (ICU) or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized (NH) and continues activities.
Query!
Timepoint [10]
0
0
Day 8
Query!
Secondary outcome [11]
0
0
Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir
Query!
Assessment method [11]
0
0
Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.
Query!
Timepoint [11]
0
0
Up to 28 Days
Query!
Secondary outcome [12]
0
0
Time to Return to Premorbid Functional Status
Query!
Assessment method [12]
0
0
Time to return to premorbid functional status (time to return usual activities) was defined as time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 7 (Have you returned to your usual activities today?).
Query!
Timepoint [12]
0
0
Up to Day 33
Query!
Secondary outcome [13]
0
0
Time to Hospital Discharge
Query!
Assessment method [13]
0
0
Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge.
Query!
Timepoint [13]
0
0
Up to 28 Days
Query!
Secondary outcome [14]
0
0
Time to Return to Usual Health
Query!
Assessment method [14]
0
0
Time to return to usual health was defined as the time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 9 (Have you returned to your health today?).
Query!
Timepoint [14]
0
0
Up to Day 33
Query!
Secondary outcome [15]
0
0
Time to Significant Reduction in FLU-PRO Influenza Symptom Severity
Query!
Assessment method [15]
0
0
Time to significant reduction in influenza symptom severity (mild/none) is time from first dose of investigational drug until first of 2 successive recordings in which total score for each of 2 recordings is lower or equal to 1 and all domain scores is lower or equal to 1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on 5-point scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e, vomiting/diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing and coughed up mucus or phlegm evaluated on scale from 0=Never to 4=Always. FLU-PRO total score is computed as mean score across all 32 items and ranges from 0 (symptom free) to 4 (very severe symptoms).
Query!
Timepoint [15]
0
0
Up to Day 33
Query!
Secondary outcome [16]
0
0
Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)
Query!
Assessment method [16]
0
0
Percentage of participants with significant reduction in influenza symptom severity was defined as time from first dose of investigational product until first of 2 successive recordings in which FLU-PRO total score for each of 2 recordings \<= to 1 and all FLU-PRO domain scores is \<=1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on a 5-point ordinal scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed as numerical frequency i.e, vomiting or diarrhea (0-4 or more times); with frequency of sneezing, coughing, coughed up mucus or phlegm evaluated on a scale from 0 (Never)-4 (Always). FLU-PRO total score is computed as a mean score across all 32 items comprising instrument and ranges from 0 (symptom free) to 4 (very severe symptoms).
Query!
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
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/12/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/03/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
102
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Cairns
Query!
Recruitment hospital [2]
0
0
- South Brisbane
Query!
Recruitment hospital [3]
0
0
- Westmead
Query!
Recruitment postcode(s) [1]
0
0
- Cairns
Query!
Recruitment postcode(s) [2]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
- Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Aalst
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Bruxelles
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Leuven
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Passo Fundo
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Porto Alegre
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Sao Paulo
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Dijon
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Grenoble
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Limoges
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Lyon
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Nantes
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Paris
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Poitiers
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Rennes
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Saint-Priest en Jarez
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Tours Cedex 9
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Donaustauf
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Jena
Query!
Country [30]
0
0
Hong Kong
Query!
State/province [30]
0
0
Hong Kong
Query!
Country [31]
0
0
Malaysia
Query!
State/province [31]
0
0
Kota Bharu
Query!
Country [32]
0
0
Malaysia
Query!
State/province [32]
0
0
Kuala Lumpur
Query!
Country [33]
0
0
Malaysia
Query!
State/province [33]
0
0
Kuala
Query!
Country [34]
0
0
Malaysia
Query!
State/province [34]
0
0
Kuching
Query!
Country [35]
0
0
Malaysia
Query!
State/province [35]
0
0
Melaka
Query!
Country [36]
0
0
Malaysia
Query!
State/province [36]
0
0
Miri
Query!
Country [37]
0
0
Malaysia
Query!
State/province [37]
0
0
Sungai Buloh
Query!
Country [38]
0
0
Malaysia
Query!
State/province [38]
0
0
Taiping
Query!
Country [39]
0
0
Netherlands
Query!
State/province [39]
0
0
Rotterdam
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
Utrecht
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Zutphen
Query!
Country [42]
0
0
New Zealand
Query!
State/province [42]
0
0
Hamilton
Query!
Country [43]
0
0
Singapore
Query!
State/province [43]
0
0
Singapore
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Alicante
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Barcelona
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Bizkaia
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Elche
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Granada
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Madrid
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Mataró
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
San Sebastián
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Vigo
Query!
Country [53]
0
0
Sweden
Query!
State/province [53]
0
0
Malmö
Query!
Country [54]
0
0
Sweden
Query!
State/province [54]
0
0
Umeå
Query!
Country [55]
0
0
Sweden
Query!
State/province [55]
0
0
Uppsala
Query!
Country [56]
0
0
Turkey
Query!
State/province [56]
0
0
Ankara
Query!
Country [57]
0
0
Turkey
Query!
State/province [57]
0
0
Eskisehir
Query!
Country [58]
0
0
Turkey
Query!
State/province [58]
0
0
Istanbul
Query!
Country [59]
0
0
Turkey
Query!
State/province [59]
0
0
Izmir
Query!
Country [60]
0
0
Turkey
Query!
State/province [60]
0
0
Trabzon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02532283
Query!
Trial related presentations / publications
O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/83/NCT02532283/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/83/NCT02532283/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02532283
Download to PDF