A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections, Virus Diseases

In brief

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than \[\>\] 1 month to less than or equal to \[\<=\] 24 months of age) who are hospitalized with RSV infection.

Key facts

Study ID

NCT02593851

Run by

Janssen Sciences Ireland UC

People needed

45

Starts

2015-12-04

Expected to finish

2017-11-10

Last updated by the study team

2019-12-06

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
• Participant has been hospitalized for this suspected RSV infection
• Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally
• Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
• A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

You may not qualify if…

• Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
• Participant has major congenital anomalies or known cytogenetic disorders
• Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
• Participant has known or suspected hepatitis B or C infection
• Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation

Where it is running

• Study site — Kirksville, Missouri, United States
• Study site — Bahía Blanca, Argentina
• Study site — City of Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Geelong, Australia
• Study site — Hobart, Australia
• Study site — Westmead, Australia
• Study site — Anderlecht, Belgium
• Study site — Brussels, Belgium
• Study site — Charleroi, Belgium
• Study site — Edegem, Belgium
• Study site — Leuven, Belgium
• Study site — Lier, Belgium
• Study site — Curitiba, Brazil
• Study site — Porto Alegre, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Freiburg im Breisgau, Germany
• Study site — Hamm, Germany
• Study site — Heidelberg, Germany
• Study site — München, Germany
• Study site — Hoofddorp, Netherlands
• Study site — Utrecht, Netherlands
• Study site — Cebu City, Philippines

Full record on ClinicalTrials.gov

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