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)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus Infections
In brief
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.
Key facts
- Study ID
- NCT04056611
- Run by
- Janssen Sciences Ireland UC
- People needed
- 3
- Starts
- 2019-12-26
- Expected to finish
- 2022-02-04
- Last updated by the study team
- 2025-02-04
Who can join
Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Henry Ford Hospital - Hematology/oncology — Detroit, Michigan, United States
- University Of Minnesota — Minneapolis, Minnesota, United States
- Northwell Health Cancer Institute — Lake Success, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Baylor Scott and White Research Institute — Dallas, Texas, United States
- MD Anderson Cancer Center - University of Texas — Houston, Texas, United States
- Hospital Espanol De Bahia Blanca — Bahía Blanca, Argentina
- Hospital Italiano de La Plata — Ciudad de La Plata, Argentina
- Sanatorio Allende — Córdoba, Argentina
- Hospital Privado-Universitario de Cordoba — Córdoba, Argentina
- Clinica Mayo de UMCB — San Miguel de Tucumán, Argentina
- Peter MacCallum Cancer Centre — Melbourne, Australia
- Royal Melbourne Hospital — Melbourne, Australia
- Westmead Hospital — Westmead, Australia
- AZ Sint-Jan — Bruges, Belgium
- Jules Bordet Institute — Brussels, Belgium
- UZ Brussel — Brussels, Belgium
- UZ Gent — Ghent, Belgium
- UZ Leuven — Leuven, Belgium
- CHU de Liege — Liège, Belgium
- Jessa Ziekenhuis — Limbourg, Belgium
- Fundacao Pio XII — Barretos, Brazil
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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