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Protocol Number53718678RSV2005
NCT Number(ClinicalTrials.gov Identfier)NCT04056611

2019-10-31 - 2022-02-04

Phase II

Suspended4

ICD-10B97.4

Respiratory syncytial virus as the cause of diseases classified elsewhere

ICD-9079.6

Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site

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.

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Sciences Ireland UC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Principal Investigator - - Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Condition/Disease

Respiratory Syncytial Virus Infections

Objectives

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.

Test Drug

JNJ-53718678

Active Ingredient

JNJ-53718678

Dosage Form

Oral suspension

Dosage

23 mg/ml

Endpoints

Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) [ Time Frame: Up to Day 28 ]

Inclution Criteria

1.Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
2.Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)
3.Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
4.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
5.Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air

Exclusion Criteria

1.Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
2.Requires supplemental oxygen at Screening or any time between Screening and randomization
3.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)
4.Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    249 participants

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