Study Phase 2

A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

  • 1 CSR Summary Not Yet Available
  • 1 NCT04068792 Not Available
  • 1 Primary Citation Trial has yet to be published
  • Data Specification Not Available

Trial Information

Generic NameRilematovirProduct NameTherapeutic AreaViral DiseasesEnrollment22% Female31.80%%% White4.50%%
Product ClassRSV Fusion InhibitorSponsor Protocol Number53718678RSV2006Data PartnerJohnson & JohnsonCondition StudiedRespiratory Syncytial VirusesMean/Median Age (Years)3.6

Supporting Documentation

  • Collected Datasets Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.