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

Janssen Pharmaceutical K.K.0 sites3 target enrollmentMarch 12, 2020

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Janssen Pharmaceutical K.K.
Enrollment: 3
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The Sponsor took the strategic decision to prematurely terminate the study, mainly due to very low participant recruitment. Therefore, insufficient data were available to draw any conclusions. No safety concerns were determined in the 3 participants enrolled in the study.

Registry

who.int

Start Date

March 12, 2020

End Date

February 4, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Janssen Pharmaceutical K.K.

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