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Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

10 september 2021 uppdaterad av: MedImmune LLC

A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Studietyp

Interventionell

Inskrivning (Faktisk)

31

Fas

  • Fas 1

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 2 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Previously healthy
  • Age 24 months and younger at the time of randomization
  • Gestational age of 36 weeks gestation and older
  • Randomization within 24 hours after hospitalization
  • Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Exclusion Criteria:

  • Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
  • Required intubation for ventilatory support
  • Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
  • Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
  • Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
  • Mechanical ventilation at any time prior to the onset of the current RSV infection
  • Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
  • Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
  • Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
  • Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
  • Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Experimentell: Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Experimentell: Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Biologisk: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Andra namn:
  • MEDI-524
Placebo-jämförare: Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
Övrig: Placebo
Single dose of placebo administered intravenously (in the vein) on Day 0

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Tidsram: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
From the start of treatment to 30 days after dosing
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
Tidsram: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
From the start of treatment to 30 days after dosing
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
Tidsram: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
From the start of treatment to 30 days after dosing
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
Tidsram: Day 2 and Day 30
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
Day 2 and Day 30

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Tidsram: Immediately before dosing on Day 0
The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
Immediately before dosing on Day 0
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
Tidsram: Day 30
The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
Day 30

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

MedImmune LLC

Utredare

  • Studierektor: Genevieve A Losonsky, MD, MedImmune LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2004

Primärt slutförande (Faktisk)

1 januari 2005

Avslutad studie (Faktisk)

1 januari 2005

Studieregistreringsdatum

Först inskickad

13 september 2005

Först inskickad som uppfyllde QC-kriterierna

13 september 2005

Första postat (Uppskatta)

19 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2021

Senast verifierad

1 oktober 2006

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MI-CP106

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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