NCT03333317

A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 28 Days – 36 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).

Detailed description

RSV is a leading cause of lower respiratory tract disease in infants. Most infants and children who get RSV recover fully after 1-2 weeks, but RSV infection can sometimes worsen and may lead to hospitalization and admission into an intensive care unit. The main purpose of this study is to learn how well the study drug (lumicitabine, also known as JNJ-64041575 or ALS-008176) works, how the human body handles the study drug, which dose of the study drug is effective for treatment of RSV infection in infants/children and how safe it is compared to a placebo (placebo looks just like lumicitabine \[given in same way\] but has no effect against RSV). Approximately up to 180 participants aged between 28 days to 36 months and hospitalized with RSV infection will take part in this world-wide study.

Conditions

• Respiratory Syncytial Viruses

Interventions

Type	Name	Description
DRUG	Lumicitabine	Participants will receive oral administration of lumicitabine.
DRUG	Placebo	Participants will receive oral administration of matching placebo.

Timeline

• Start date: 2017-11-24
• Primary completion: 2018-03-23
• Completion: 2018-03-23
• First posted: 2017-11-06
• Last updated: 2019-12-23
• Results posted: 2019-12-05

Locations

29 sites across 6 countries: United States, Belgium, Canada, Hungary, Japan, Poland

Regulatory

• FDA-regulated drug study