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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02016690
First received: December 11, 2013
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
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.

Condition
Respiratory Syncytial Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 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).

  • Number of Participants With Serious Adverse Events [ Time Frame: 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).

  • Number of Participants With Adverse Drug Reactions [ Time Frame: 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).


Secondary Outcome Measures:
  • Change in Lower Respiratory Tract Infection (LRI) Score During the Study [ Time Frame: 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).

  • Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection [ Time Frame: 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).

  • Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection [ Time Frame: 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).

  • Number of Hospitalized Participants Requiring Respiratory Support [ Time Frame: 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).

  • Mean Duration of Respiratory Support [ Time Frame: 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).


Enrollment: 312
Study Start Date: December 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Immunocompromised children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single-arm, Multi-center, Prospective Cohort
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016690

Sponsors and Collaborators
AbbVie
Investigators
Study Director: Osamu Mikami, MD, PhD Abbvie GK
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02016690     History of Changes
Other Study ID Numbers: P14-296
Study First Received: December 11, 2013
Results First Received: December 16, 2016
Last Updated: February 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AbbVie:
Prevention of severe RSV infection
Respiratory syncytial virus (RSV) infection
Down Syndrome
Immunocompromised
Effectiveness of palivizumab

Additional relevant MeSH terms:
Infection
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017