Clinical trial NCT04056611: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 3
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

Detailed description: RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.

Eligibility criteria: 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

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

Primary outcomes:
measure: Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
timeFrame: Up to Day 28
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 49
measure: Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
timeFrame: Up to Day 49
measure: Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
timeFrame: Up to Day 49
measure: Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
timeFrame: Up to Day 49
measure: 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
timeFrame: Up to Day 49
measure: Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
timeFrame: Up to Day 49
measure: 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
timeFrame: Up to Day 49
measure: Percentage of Participants Who Progressed to Death (All-cause Mortality)
timeFrame: Up to Day 49
measure: 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
timeFrame: Up to Day 49
measure: Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
timeFrame: Up to Day 49
measure: Number of Supplemental Oxygen Free Days
timeFrame: Through Day 28
measure: Percentage of Participants With Treatment-emergent Oxygen Supplementation
timeFrame: Up to Day 49
measure: Respiratory Rate Over Time
timeFrame: Baseline (Day 1), Days 15, 28, and 35
measure: Heart Rate Over Time
timeFrame: Baseline (Day 1), Days 15, 28, and 35
measure: Peripheral Capillary Oxygen Saturation (SpO2) Over Time
timeFrame: Baseline (Day 1), Days 15, 28, and 35
measure: Body Temperature Over Time
timeFrame: Baseline (Day 1), Days 15, 28, and 35
measure: Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
timeFrame: Up to Day 49
measure: Percentage of Participants Who Were Re-hospitalized
timeFrame: Up to Day 49
measure: Duration of Hospital Stay
timeFrame: Up to Day 49
measure: Duration of Intensive Care Unit (ICU) Stay
timeFrame: Up to Day 49
measure: Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
timeFrame: Up to Day 49
measure: Number of Participants With Respiratory Related AEs
timeFrame: Up to Day 49
measure: Number of Participants With Thoracic-related AEs
timeFrame: Up to Day 49
measure: Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
timeFrame: Up to Day 49
measure: Plasma Concentration of JNJ-53718678
timeFrame: Days 1, 3, 8, 15 and 22
measure: RSV Viral Load Over Time
timeFrame: Baseline (Day 1), Days 15, 28, and 35
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital - Hematology/oncology
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center - University of Texas
state: Texas
city: Bahia Blanca
country: Argentina
facility: Hospital Espanol De Bahia Blanca
city: Ciudad De La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Cordoba
country: Argentina
facility: Hospital Privado-Universitario de Cordoba
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de UMCB
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liege
city: Limburg
country: Belgium
facility: Jessa Ziekenhuis
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Florianopolis
country: Brazil
facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceara Hospital Universitario Walter Cantidio
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
city: Plovdiv
country: Bulgaria
facility: UMHAT 'Sveti Georgi'-Plovdiv
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Haematologic Diseases
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky (Ichilov) Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
city: Roma
country: Italy
facility: Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
city: Akita
country: Japan
facility: Akita University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Nagano
country: Japan
facility: Japanese Red Cross Society Nagano Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Ampang Jaya
country: Malaysia
facility: Hospital Ampang
city: Georgetown
country: Malaysia
facility: Penang General Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Malmö
country: Sweden
facility: Skanes universitetssjukhus
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Trust
Study officials:
affiliation: Janssen Sciences Ireland UC
name: Janssen Sciences Ireland UC Clinical Trial
role: STUDY_DIRECTOR
References: