Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®

10. februar 2017 opdateret af: AbbVie
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of serious lower respiratory tract infection caused by RSV in participants 24 months of age and under, who have an immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Down syndrome.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

312

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 2 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Single-arm, Multi-center, Prospective Cohort

Beskrivelse

Inclusion Criteria:

  1. Availability of a parent or legal guardian who was capable and willing to give written informed consent for his/her newborn, infant or young child to participate in the study
  2. Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection

  3. Newborns, infants, or young children 24 months of age and under who have an immunocompromised medical condition:

    • combined immunodeficiency, (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia,common variable immunodeficiency, non-X-linked hyper-IgM syndrome,etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, etc.)
    • acquired T cell dysfunction ( such as human immunodeficiency virus (HIV) infection etc.)
    • history of past organ transplantation
    • history of past bone marrow transplantation
    • receiving immunosuppressive chemotherapy
    • receiving systemic high-dose corticosteroid therapy (prednisone equivalents ≥ 0.5 mg/kg/every other day, other than inhaler or topical use), or
    • receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.)
    • receiving biologics (including cytokine inhibitors)
    • Others (nephrotic syndrome, chronic peritoneal dialysis, hemodialysis)
  4. Newborns, infants, or young children age of 24 months and under who have Down syndrome without a current hemodynamically significant Congenital Heart Disease. The participant must have had an experience with persistent respiratory symptoms or regular outpatient treatment due to respiratory tract infection prior to current RSV season.

Exclusion criteria:

  1. Participants included in the Contraindications section of the package insert
  2. Participants with known hypersensitivity to the ingredients of palivizumab
  3. Participants with a known positive RSV infection before hospitalization

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Immunocompromised children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Serious Adverse Events
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Adverse Drug Reactions
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Tidsramme: From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Hospitalized Participants Requiring Respiratory Support
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Duration of Respiratory Support
Tidsramme: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Efterforskere

  • Studieleder: Osamu Mikami, MD, PhD, AbbVie GK.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2013

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

11. december 2013

Først indsendt, der opfyldte QC-kriterier

16. december 2013

Først opslået (Skøn)

20. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P14-296

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Respiratorisk syncytial virusinfektion

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kosovo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner