Status:
TERMINATED
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)
Lead Sponsor:
Janssen Sciences Ireland UC
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
13-75 years
Phase:
PHASE2
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 t...
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) parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04056611
Start Date
December 26 2019
End Date
February 4 2022
Last Update
February 4 2025
Active Locations (69)
Enter a location and click search to find clinical trials sorted by distance.
1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
Henry Ford Hospital - Hematology/oncology
Detroit, Michigan, United States, 48202
3
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Northwell Health Cancer Institute
Lake Success, New York, United States, 11042