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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04056611




Registration number
NCT04056611
Ethics application status
Date submitted
13/08/2019
Date registered
14/08/2019

Titles & IDs
Public title
Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Secondary ID [1] 0 0
53718678RSV2005
Secondary ID [2] 0 0
CR108662
Universal Trial Number (UTN)
Trial acronym
FREESIA
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 250 mg
Treatment: Drugs - Placebo
Treatment: Drugs - JNJ-53718678 125 mg

Experimental: Adult cohort: JNJ-53718678 or Placebo - Participants greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years of age will receive 250 milligram (mg) JNJ-53718678 twice daily (bid) for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg once daily (qd) for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.

Experimental: Adolescent cohort: JNJ-53718678 or Placebo - Participants \>=13 to \<18 years of age will receive 250 mg JNJ-53718678 bid for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg qd for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.


Treatment: Drugs: JNJ-53718678 250 mg
JNJ-53718678 250 mg will be administered orally.

Treatment: Drugs: Placebo
Matching placebo will be administered orally.

Treatment: Drugs: JNJ-53718678 125 mg
JNJ-53718678 125 mg will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [1] 0 0
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to Day 49
Secondary outcome [3] 0 0
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
Timepoint [3] 0 0
Up to Day 49
Secondary outcome [4] 0 0
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
Timepoint [4] 0 0
Up to Day 49
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Timepoint [5] 0 0
Up to Day 49
Secondary outcome [6] 0 0
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Timepoint [6] 0 0
Up to Day 49
Secondary outcome [7] 0 0
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
Timepoint [7] 0 0
Up to Day 49
Secondary outcome [8] 0 0
Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Timepoint [8] 0 0
Up to Day 49
Secondary outcome [9] 0 0
Percentage of Participants Who Progressed to Death (All-cause Mortality)
Timepoint [9] 0 0
Up to Day 49
Secondary outcome [10] 0 0
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Timepoint [10] 0 0
Up to Day 49
Secondary outcome [11] 0 0
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
Timepoint [11] 0 0
Up to Day 49
Secondary outcome [12] 0 0
Number of Supplemental Oxygen Free Days
Timepoint [12] 0 0
Through Day 28
Secondary outcome [13] 0 0
Percentage of Participants With Treatment-emergent Oxygen Supplementation
Timepoint [13] 0 0
Up to Day 49
Secondary outcome [14] 0 0
Respiratory Rate Over Time
Timepoint [14] 0 0
Baseline (Day 1), Days 15, 28, and 35
Secondary outcome [15] 0 0
Heart Rate Over Time
Timepoint [15] 0 0
Baseline (Day 1), Days 15, 28, and 35
Secondary outcome [16] 0 0
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Timepoint [16] 0 0
Baseline (Day 1), Days 15, 28, and 35
Secondary outcome [17] 0 0
Body Temperature Over Time
Timepoint [17] 0 0
Baseline (Day 1), Days 15, 28, and 35
Secondary outcome [18] 0 0
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
Timepoint [18] 0 0
Up to Day 49
Secondary outcome [19] 0 0
Percentage of Participants Who Were Re-hospitalized
Timepoint [19] 0 0
Up to Day 49
Secondary outcome [20] 0 0
Duration of Hospital Stay
Timepoint [20] 0 0
Up to Day 49
Secondary outcome [21] 0 0
Duration of Intensive Care Unit (ICU) Stay
Timepoint [21] 0 0
Up to Day 49
Secondary outcome [22] 0 0
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
Timepoint [22] 0 0
Up to Day 49
Secondary outcome [23] 0 0
Number of Participants With Respiratory Related AEs
Timepoint [23] 0 0
Up to Day 49
Secondary outcome [24] 0 0
Number of Participants With Thoracic-related AEs
Timepoint [24] 0 0
Up to Day 49
Secondary outcome [25] 0 0
Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
Timepoint [25] 0 0
Up to Day 49
Secondary outcome [26] 0 0
Plasma Concentration of JNJ-53718678
Timepoint [26] 0 0
Days 1, 3, 8, 15 and 22
Secondary outcome [27] 0 0
RSV Viral Load Over Time
Timepoint [27] 0 0
Baseline (Day 1), Days 15, 28, and 35

Eligibility
Key inclusion criteria
* Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
* Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)
* Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
* New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing
* Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air
Minimum age
13 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
* Requires supplemental oxygen at Screening or any time between Screening and randomization
* Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)
* Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2022
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
2145 - 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
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Bahia Blanca
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad De La Plata
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Argentina
State/province [11] 0 0
San Miguel de Tucuman
Country [12] 0 0
Belgium
State/province [12] 0 0
Brugge
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
Country [17] 0 0
Belgium
State/province [17] 0 0
Limburg
Country [18] 0 0
Brazil
State/province [18] 0 0
Barretos
Country [19] 0 0
Brazil
State/province [19] 0 0
Belo Horizonte
Country [20] 0 0
Brazil
State/province [20] 0 0
Florianopolis
Country [21] 0 0
Brazil
State/province [21] 0 0
Fortaleza
Country [22] 0 0
Brazil
State/province [22] 0 0
Jau
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Jose do Rio Preto
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Varna
Country [30] 0 0
France
State/province [30] 0 0
Clamart
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Israel
State/province [34] 0 0
Ramat Gan
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Aviv
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Japan
State/province [38] 0 0
Akita
Country [39] 0 0
Japan
State/province [39] 0 0
Chiba
Country [40] 0 0
Japan
State/province [40] 0 0
Isehara
Country [41] 0 0
Japan
State/province [41] 0 0
Nagano
Country [42] 0 0
Japan
State/province [42] 0 0
Okayama
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Malaysia
State/province [44] 0 0
Ampang Jaya
Country [45] 0 0
Malaysia
State/province [45] 0 0
Georgetown
Country [46] 0 0
Malaysia
State/province [46] 0 0
Kuala Lumpur
Country [47] 0 0
Malaysia
State/province [47] 0 0
Petaling Jaya, Selangor
Country [48] 0 0
Netherlands
State/province [48] 0 0
Leiden
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Salamanca
Country [52] 0 0
Spain
State/province [52] 0 0
Santander
Country [53] 0 0
Spain
State/province [53] 0 0
Sevilla
Country [54] 0 0
Sweden
State/province [54] 0 0
Malmö
Country [55] 0 0
Taiwan
State/province [55] 0 0
Kaohsiung
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Tainan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Sciences Ireland UC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Sciences Ireland UC Clinical Trial
Address 0 0
Janssen Sciences Ireland UC
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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/NCT04056611