Effects of JNJ-53718678 in HSCT Patients who are infected with RSV
Research type
Research Study
Full title
A Randomised, 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
IRAS ID
270251
Contact name
Antonio Pagliuca
Contact email
Sponsor organisation
Janssen Sciences Ireland UC
Eudract number
2019-001551-39
Duration of Study in the UK
2 years, 10 months, 6 days
Research summary
The purpose of this research study is to see how well and how safely a study medicine (called ‘JNJ-53718678’) works in adults who are Haematopoietic Stem Cell transplant (HSCT) recipients with Respiratory Syncytial Virus (RSV) Upper Respiratory Tract Infection (URTI). The study also looks at how much JNJ-53718678 is taken up in the blood, how long it stays there and how the body handles it.
The study is made up of three parts: screening period (2 days), treatment period (21 days) and follow-up period (27 days). The study compares two treatments: a dose of JNJ-53718678 and a dummy medicine (or placebo). Both treatments are liquids given for 21 days (once a day) using an oral dosing pipette. There is a two in three chance that a participant will receive JNJ-53718678, and a one in three chance that a participant will receive placebo.
At screening, a participant with RSV signs the study informed consent form. They then undergo various tests and assessments to see if they can enter the study. These include a nasal swab, an electrocardiogram, chest X-ray, blood and urine test. If the participant is eligible to take part, it will then be decided by chance which treatment they receive. During the treatment and follow-up periods, the participant will have further tests and assessments, and will be continually monitored. The participant will be asked to complete a diary each day answering questions about their RSV symptoms.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1550
Date of REC Opinion
14 Nov 2019
REC opinion
Further Information Favourable Opinion