- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02016690
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
10 februari 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
312
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
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Single-arm, Multi-center, Prospective Cohort
Beskrivning
Inclusion Criteria:
- 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
- Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection
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)
- 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:
- Participants included in the Contraindications section of the package insert
- Participants with known hypersensitivity to the ingredients of palivizumab
- Participants with a known positive RSV infection before hospitalization
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Immunocompromised children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Adverse Events
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Osamu Mikami, MD, PhD, AbbVie GK.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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 december 2013
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
11 december 2013
Först inskickad som uppfyllde QC-kriterierna
16 december 2013
Första postat (Uppskatta)
20 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P14-296
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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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