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 May 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02016690
First received: December 11, 2013
Last updated: May 2, 2014
Last verified: May 2014
  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: December 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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: Tadamichi Kubo +81-3-4577-9333 tadamichi.kubo@abbvie.com

Locations
Japan
Site Reference ID/Investigator# 124803 Recruiting
Akita, Japan
Principal Investigator: Site Reference ID/Investigator# 124803         
Site Reference ID/Investigator# 126959 Not yet recruiting
Azumino-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126959         
Site Reference ID/Investigator# 126958 Not yet recruiting
Fuchu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126958         
Site Reference ID/Investigator# 126957 Not yet recruiting
Fuchu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126957         
Site Reference ID/Investigator# 124796 Recruiting
Hirakata-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124796         
Site Reference ID/Investigator# 124806 Not yet recruiting
Hofu, Japan
Principal Investigator: Site Reference ID/Investigator# 124806         
Site Reference ID/Investigator# 126554 Not yet recruiting
Isehara-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126554         
Site Reference ID/Investigator# 126965 Not yet recruiting
Kawagoe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126965         
Site Reference ID/Investigator# 128455 Not yet recruiting
Kobe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 128455         
Site Reference ID/Investigator# 126551 Not yet recruiting
Matsumoto-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126551         
Site Reference ID/Investigator# 124807 Not yet recruiting
Morioka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124807         
Site Reference ID/Investigator# 126964 Not yet recruiting
Moriyama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126964         
Site Reference ID/Investigator# 124805 Recruiting
Nagakute-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124805         
Site Reference ID/Investigator# 124795 Not yet recruiting
Nagasaki, Japan
Principal Investigator: Site Reference ID/Investigator# 124795         
Site Reference ID/Investigator# 126550 Not yet recruiting
Niigata-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126550         
Site Reference ID/Investigator# 126556 Not yet recruiting
Nishinomiya-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126556         
Site Reference ID/Investigator# 124802 Not yet recruiting
Saga, Japan
Principal Investigator: Site Reference ID/Investigator# 124802         
Site Reference ID/Investigator# 124797 Recruiting
Saitama, Japan
Principal Investigator: Site Reference ID/Investigator# 124797         
Site Reference ID/Investigator# 124798 Recruiting
Saitama, Japan
Principal Investigator: Site Reference ID/Investigator# 124798         
Site Reference ID/Investigator# 126954 Not yet recruiting
Sapporo-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126954         
Site Reference ID/Investigator# 124799 Not yet recruiting
Shibukawa, Japan
Principal Investigator: Site Reference ID/Investigator# 124799         
Site Reference ID/Investigator# 126961 Not yet recruiting
Shimotsuke-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126961         
Site Reference ID/Investigator# 126962 Not yet recruiting
Shimotsuke-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126962         
Site Reference ID/Investigator# 126956 Not yet recruiting
Shizuoka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126956         
Site Reference ID/Investigator# 126559 Not yet recruiting
Suita-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126559         
Site Reference ID/Investigator# 126955 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126955         
Site Reference ID/Investigator# 128456 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 128456         
Site Reference ID/Investigator# 124800 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 124800         
Site Reference ID/Investigator# 126552 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126552         
Site Reference ID/Investigator# 126553 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126553         
Site Reference ID/Investigator# 111755 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 111755         
Site Reference ID/Investigator# 124808 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 124808         
Site Reference ID/Investigator# 124801 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 124801         
Site Reference ID/Investigator# 124809 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 124809         
Site Reference ID/Investigator# 126549 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126549         
Site Reference ID/Investigator# 126967 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126967         
Site Reference ID/Investigator# 126555 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 126555         
Site Reference ID/Investigator# 124804 Not yet recruiting
Toon-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124804         
Site Reference ID/Investigator# 124810 Not yet recruiting
Tsu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124810         
Site Reference ID/Investigator# 126557 Not yet recruiting
Yokohama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126557         
Site Reference ID/Investigator# 126558 Not yet recruiting
Yokohama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126558         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Yo Hoshino 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: May 2, 2014
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
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014