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NCT03502694: STEP

Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus

Withdrawn Phase 2 Last updated 15 November 2018
What this trial tests

Phase 2 trial testing Lumicitabine in Metapneumovirus. Withdrawn.

Timeline
5 November 2018
Primary endpoint
30 April 2019
28 October 2020

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Start date5 November 2018
Primary completion30 April 2019
Estimated completion28 October 2020
Sites112 locations across France, Japan, Netherlands, Russia, Malaysia, Ukraine, Sweden, Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Metapneumovirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Respiratory Viral Infections in Patients With Cancer or Undergoing Hematopoietic Cell Transplant.
    Hijano DR, Maron G, Hayden RT. · · 2018 · cited 69× · PMID 30619176 · DOI 10.3389/fmicb.2018.03097
  2. Are Community Acquired Respiratory Viral Infections an Underestimated Burden in Hematology Patients?
    Popescu CM, Ursache AL, Feketea G, Bocsan C, et al · · 2019 · cited 9× · PMID 31684063 · DOI 10.3390/microorganisms7110521

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Other trials of Lumicitabine

Trials testing the same drug.

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03502694.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing