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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03379675




Registration number
NCT03379675
Ethics application status
Date submitted
15/12/2017
Date registered
20/12/2017
Date last updated
4/02/2025

Titles & IDs
Public title
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Scientific title
A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
Secondary ID [1] 0 0
2017-003252-24
Secondary ID [2] 0 0
CR108419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 500 mg
Treatment: Drugs - JNJ-53718678 80 mg
Treatment: Drugs - Placebo

Experimental: Treatment A: JNJ-53718678 500 mg - Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.

Experimental: Treatment B: JNJ-53718678 80 mg + Placebo - Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Placebo comparator: Treatment C: Placebo - Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.


Treatment: Drugs: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Treatment: Drugs: JNJ-53718678 80 mg
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Treatment: Drugs: Placebo
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
Assessment method [1] 0 0
Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Timepoint [1] 0 0
Baseline through Day 3
Primary outcome [2] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Assessment method [2] 0 0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Timepoint [2] 0 0
Baseline through Day 5
Primary outcome [3] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Assessment method [3] 0 0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Timepoint [3] 0 0
Baseline through Day 8
Primary outcome [4] 0 0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Assessment method [4] 0 0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Timepoint [4] 0 0
Baseline through Day 14
Primary outcome [5] 0 0
Change From Baseline in RSV Viral Load at Day 3
Assessment method [5] 0 0
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [5] 0 0
Baseline to Day 3
Primary outcome [6] 0 0
Change From Baseline in RSV Viral Load at Day 5
Assessment method [6] 0 0
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [6] 0 0
Baseline to Day 5
Primary outcome [7] 0 0
Change From Baseline in RSV Viral Load at Day 8
Assessment method [7] 0 0
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [7] 0 0
Baseline to Day 8
Primary outcome [8] 0 0
Change From Baseline in RSV Viral Load at Day 14
Assessment method [8] 0 0
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [8] 0 0
Baseline to Day 14
Primary outcome [9] 0 0
Change From Baseline in RSV Viral Load at Day 21
Assessment method [9] 0 0
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [9] 0 0
Baseline to Day 21
Primary outcome [10] 0 0
RSV Viral Load at Baseline
Assessment method [10] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
RSV Viral Load at Day 3
Assessment method [11] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [11] 0 0
Day 3
Primary outcome [12] 0 0
RSV Viral Load at Day 5
Assessment method [12] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [12] 0 0
Day 5
Primary outcome [13] 0 0
RSV Viral Load at Day 8
Assessment method [13] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [13] 0 0
Day 8
Primary outcome [14] 0 0
RSV Viral Load at Day 14
Assessment method [14] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [14] 0 0
Day 14
Primary outcome [15] 0 0
RSV Viral Load at Day 21
Assessment method [15] 0 0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [15] 0 0
Day 21
Primary outcome [16] 0 0
Time to Undetectable RSV Viral Load
Assessment method [16] 0 0
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Timepoint [16] 0 0
Up to Day 21
Primary outcome [17] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Assessment method [17] 0 0
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Timepoint [17] 0 0
Day 3
Primary outcome [18] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Assessment method [18] 0 0
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Timepoint [18] 0 0
Day 5
Primary outcome [19] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Assessment method [19] 0 0
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Timepoint [19] 0 0
Day 8
Primary outcome [20] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Assessment method [20] 0 0
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Timepoint [20] 0 0
Day 14
Primary outcome [21] 0 0
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Assessment method [21] 0 0
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Timepoint [21] 0 0
Day 21
Secondary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Assessment method [1] 0 0
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Assessment method [2] 0 0
Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (\< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
Timepoint [2] 0 0
Up to Day 28
Secondary outcome [3] 0 0
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Assessment method [3] 0 0
Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (\<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - \< 100 mmHg, Grade 2 (moderate)- greater than or equal to (\>=)100 mmHg to \< 110 mmHg, Grade 3 (severe)- \>=110 mmHg; DBP: Abnormally low- \<=90 mmHg, Grade 1 (mild)- 140 mmHg - \< 160 mmHg, Grade 2 (moderate)- \>=160 mmHg to \< 180 mmHg, Grade 3 (severe)- \>=180 mmHg.
Timepoint [3] 0 0
Up to Day 28
Secondary outcome [4] 0 0
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
Assessment method [4] 0 0
The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]).
Timepoint [4] 0 0
Up to Day 28
Secondary outcome [5] 0 0
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Assessment method [5] 0 0
Peripheral capillary oxygen saturation was measured by the investigator over time.
Timepoint [5] 0 0
Baseline, Days 3, 8, 14, and 21
Secondary outcome [6] 0 0
Change From Baseline in Peripheral Capillary Oxygen Saturation
Assessment method [6] 0 0
Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.
Timepoint [6] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [7] 0 0
Pulse Rate Over Time
Assessment method [7] 0 0
Pulse rate was measured by the investigator over time.
Timepoint [7] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [8] 0 0
Change From Baseline in Pulse Rate
Assessment method [8] 0 0
Change from baseline in pulse rate was calculated and reported by the investigator.
Timepoint [8] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [9] 0 0
Respiratory Rate Over Time
Assessment method [9] 0 0
Respiratory rate was measured by the investigator over time.
Timepoint [9] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [10] 0 0
Change From Baseline in Respiratory Rate
Assessment method [10] 0 0
Change from baseline in respiratory rate was calculated and reported by the investigator.
Timepoint [10] 0 0
Baseline to Days 3, 8, 14 and 21
Secondary outcome [11] 0 0
Body Temperature Over Time
Assessment method [11] 0 0
Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Timepoint [11] 0 0
Baseline, Days 3, 8, 14 and 21
Secondary outcome [12] 0 0
Change From Baseline in Body Temperature
Assessment method [12] 0 0
Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Timepoint [12] 0 0
Baseline to Days 3, 5, 8, 14 and 21
Secondary outcome [13] 0 0
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
Assessment method [13] 0 0
AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.
Timepoint [13] 0 0
0 to 24 hours post dose on Days 1 and 7
Secondary outcome [14] 0 0
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
Assessment method [14] 0 0
The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.
Timepoint [14] 0 0
Baseline, Days 3, 5, 8, 14 and 21
Secondary outcome [15] 0 0
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Assessment method [15] 0 0
Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Timepoint [15] 0 0
Baseline up to Day 21
Secondary outcome [16] 0 0
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Assessment method [16] 0 0
Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Timepoint [16] 0 0
Up to Day 21
Secondary outcome [17] 0 0
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Assessment method [17] 0 0
Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.
Timepoint [17] 0 0
Up to Day 21
Secondary outcome [18] 0 0
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Assessment method [18] 0 0
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Timepoint [18] 0 0
Predose on Days 1 and 7
Secondary outcome [19] 0 0
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Assessment method [19] 0 0
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Timepoint [19] 0 0
Days 1 and 7

Eligibility
Key inclusion criteria
* Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
* Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
* Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile
* A male participant must agree to the use of acceptable contraceptive measures
* With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
* History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
* Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
* Participants who are considered by the investigator to be immunocompromised within the past 12 months
* Participant has known or suspected chronic or acute hepatitis B or C infection
* Women who are pregnant or breastfeeding
* Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator

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
6/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/12/2019
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
Paratus Clinical Kippa Ring Clinic - Kippa Ring
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2060 - Blacktown
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2059 - Kanwal
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2145 - Sydney
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
Idaho
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
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
Argentina
State/province [10] 0 0
Bahia Blanca
Country [11] 0 0
Argentina
State/province [11] 0 0
Barrio Parque Velez Sarfield
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad De La Plata
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudadela
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
General Roca
Country [17] 0 0
Argentina
State/province [17] 0 0
Rosario
Country [18] 0 0
Argentina
State/province [18] 0 0
San Miguel de Tucuman
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Ham
Country [21] 0 0
Belgium
State/province [21] 0 0
Massemen
Country [22] 0 0
Belgium
State/province [22] 0 0
Tessenderlo
Country [23] 0 0
Brazil
State/province [23] 0 0
Belo Horizonte
Country [24] 0 0
Brazil
State/province [24] 0 0
Botucatu
Country [25] 0 0
Brazil
State/province [25] 0 0
Florianopolis
Country [26] 0 0
Brazil
State/province [26] 0 0
Natal
Country [27] 0 0
Brazil
State/province [27] 0 0
Passo Fundo
Country [28] 0 0
Brazil
State/province [28] 0 0
Porto Alegre
Country [29] 0 0
Brazil
State/province [29] 0 0
Salvador
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Kozloduy
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Pernik
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Ruse
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Smolyan
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sofia
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Troyan
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
France
State/province [40] 0 0
Agen cedex 9
Country [41] 0 0
France
State/province [41] 0 0
Angers
Country [42] 0 0
France
State/province [42] 0 0
Murs Erigne
Country [43] 0 0
France
State/province [43] 0 0
Nantes
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Luebeck
Country [49] 0 0
Japan
State/province [49] 0 0
Fukui-shi
Country [50] 0 0
Japan
State/province [50] 0 0
Kawasaki
Country [51] 0 0
Japan
State/province [51] 0 0
Kitakyusyu
Country [52] 0 0
Japan
State/province [52] 0 0
Koganei-Shi
Country [53] 0 0
Japan
State/province [53] 0 0
Kumamoto-shi
Country [54] 0 0
Japan
State/province [54] 0 0
Osaka
Country [55] 0 0
Japan
State/province [55] 0 0
Shinagawa-ku
Country [56] 0 0
Japan
State/province [56] 0 0
Tokorozawa-shi
Country [57] 0 0
Japan
State/province [57] 0 0
Toyota
Country [58] 0 0
Japan
State/province [58] 0 0
Yukuhashi
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Bucheon
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Daegu
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Gyeonggi-do
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Incheon
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Mexico
State/province [64] 0 0
Aguascalientes
Country [65] 0 0
Mexico
State/province [65] 0 0
Guadalajara
Country [66] 0 0
Mexico
State/province [66] 0 0
Mexico
Country [67] 0 0
Mexico
State/province [67] 0 0
Monterrey
Country [68] 0 0
Poland
State/province [68] 0 0
Kielce
Country [69] 0 0
Poland
State/province [69] 0 0
Krakow
Country [70] 0 0
Poland
State/province [70] 0 0
Lodz
Country [71] 0 0
Poland
State/province [71] 0 0
Ostrow Wielkopolski
Country [72] 0 0
Poland
State/province [72] 0 0
Wroclaw
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Krasnogorsk
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Saint-Petersburg
Country [75] 0 0
Russian Federation
State/province [75] 0 0
St. Petersburg
Country [76] 0 0
South Africa
State/province [76] 0 0
Johannesburg
Country [77] 0 0
South Africa
State/province [77] 0 0
Pretoria
Country [78] 0 0
South Africa
State/province [78] 0 0
Welkom
Country [79] 0 0
Spain
State/province [79] 0 0
Alicante
Country [80] 0 0
Spain
State/province [80] 0 0
Elche
Country [81] 0 0
Spain
State/province [81] 0 0
Granada
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Santiago de Compostela
Country [84] 0 0
Spain
State/province [84] 0 0
Vigo
Country [85] 0 0
Sweden
State/province [85] 0 0
Malmö
Country [86] 0 0
Sweden
State/province [86] 0 0
Umeå
Country [87] 0 0
Sweden
State/province [87] 0 0
Uppsala
Country [88] 0 0
Taiwan
State/province [88] 0 0
Kaohsiung
Country [89] 0 0
Taiwan
State/province [89] 0 0
New Taipei
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung City
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kharkiv
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kherson
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kyiv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Vinnytsia
Country [97] 0 0
Ukraine
State/province [97] 0 0
Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03379675