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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02016690
First received: December 11, 2013
Last updated: July 13, 2015
Last verified: July 2015
  Purpose

This is a post marketing observational study (PMOS) conducted in Japan in patients receiving palivizumab for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract infection at the age of 24 months and under, who have 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 Downs 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 Immuno Compromised Children With Synagis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: Yes ]
    Include adverse events and adverse drug reactions stratified by patient background, concomitant drugs and concomitant therapy.

  • Frequency of Serious Adverse Events [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV) [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
  • Total Number of RSV Hospitalization Days [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
  • Total RSV Hospitalizations in patients requiring respiratory support [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
    Respiratory support includes oxygen therapy, mechanical ventilation, membrane oxygenation, continuous positive airway pressure or Intensive Care Unit (ICU) admission.

  • Total Number of RSV Hospitalization days in subjects requiring respiratory support [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
    Respiratory support includes oxygen therapy, mechanical ventilation, membrane oxygenation, continuous positive airway pressure or ICU admission.

  • Rate of Hospitalization due to patient characteristics [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
    Patient Characteristics that are being considered are sex, race, age, family structure and medical history

  • Change in Lower Respiratory tract Infection (LRI) Score [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. ] [ Designated as safety issue: No ]
    The LRI score is provided by the clinical investigator after assessment.


Estimated Enrollment: 250
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Synagis Immuno Compromised Children
Patients receiving palivizumab for the prevention of RSV lower respiratory tract infection on proper use after the approval of the indication are to be enrolled.

Detailed Description:

Palivizumab will be prescribed according to the local label and independently of the decision to enroll the subject in the study. Palivizumab will be administered monthly (30 days) throughout the Respiratory Syncytial Virus (RSV) infection season. Survey forms will be collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed patients will be counted to evaluate the safety and efficacy of palivizumab.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Single-arm, Multi-center, Prospective Cohort

Criteria

Inclusion Criteria:

  1. Patients receiving palivizumab for prevention of RSV lower respiratory tract infection on proper use after the approval of the indication are to be enrolled.
  2. Children, at the age of 24 months and under, who have an immunocompromised medical condition.
  3. Children, at the age of 24 months and under, who have Down's syndrome.

Exclusion Criteria:

  1. Patients included in "Contraindication" in the package insert.
  2. Patients with known hypersensitivity to the ingredients of palivizumab.
  3. Patients with known positive RSV infection before hospitalization.
  4. A life expectancy less than 1 year.
  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

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Yasuhiko Shinmura

  Show 84 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Hiroyuki Kishimoto, MD Abbvie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02016690     History of Changes
Other Study ID Numbers: P14-296
Study First Received: December 11, 2013
Last Updated: July 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Prevention of severe RSV infection
Respiratory syncytial virus (RSV) infection
Immuno compromised
Efficacy of palivizumab
Down's Syndrome

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Mononegavirales Infections
Paramyxoviridae Infections
Pneumovirus Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 27, 2015