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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02016690
Other study ID # P14-296
Secondary ID
Status Completed
Phase N/A
First received December 11, 2013
Last updated March 16, 2016
Start date September 2013
Est. completion date December 2015

Study information

Verified date March 2016
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 328
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 24 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
  • Virus Diseases

Locations

Country Name City State
Japan Site Reference ID/Investigator# 124803 Akita
Japan Site Reference ID/Investigator# 126959 Azumino-shi
Japan Site Reference ID/Investigator# 128967 Chiba-shi
Japan Site Reference ID/Investigator# 126957 Fuchu-shi
Japan Site Reference ID/Investigator# 126958 Fuchu-shi
Japan Site Reference ID/Investigator# 129897 Fukuoka-shi
Japan Site Reference ID/Investigator# 129898 Fukuoka-shi
Japan Site Reference ID/Investigator# 133804 Fukuoka-shi
Japan Site Reference ID/Investigator# 133813 Fukushima-shi
Japan Site Reference ID/Investigator# 135036 Fukushima-shi
Japan Site Reference ID/Investigator# 133797 Hachinohe-shi
Japan Site Reference ID/Investigator# 133796 Hakodate-shi
Japan Site Reference ID/Investigator# 133814 Hamamatsu-shi
Japan Site Reference ID/Investigator# 124796 Hirakata-shi
Japan Site Reference ID/Investigator# 124806 Hofu
Japan Site Reference ID/Investigator# 126554 Isehara-shi
Japan Site Reference ID/Investigator# 126955 Itabashi-Ku,Tokyo
Japan Site Reference ID/Investigator# 133800 Izumi-shi
Japan Site Reference ID/Investigator# 133808 Izumi-shi
Japan Site Reference ID/Investigator# 133816 Izumi-shi
Japan Site Reference ID/Investigator# 133798 Kashihara-shi
Japan Site Reference ID/Investigator# 126965 Kawagoe-shi
Japan Site Reference ID/Investigator# 132115 Kitakyusyu-shi
Japan Site Reference ID/Investigator# 128455 Kobe-shi
Japan Site Reference ID/Investigator# 133811 Koriyama-shi
Japan Site Reference ID/Investigator# 132112 Kumamoto-shi
Japan Site Reference ID/Investigator# 135035 Kumamoto-shi
Japan Site Reference ID/Investigator# 126551 Matsumoto-shi
Japan Site Reference ID/Investigator# 133794 Miyazaki-shi
Japan Site Reference ID/Investigator# 124807 Morioka-shi
Japan Site Reference ID/Investigator# 126964 Moriyama-shi
Japan Site Reference ID/Investigator# 124805 Nagakute-shi
Japan Site Reference ID/Investigator# 124795 Nagasaki-shi
Japan Site Reference ID/Investigator# 133815 Nagoya-shi
Japan Site Reference ID/Investigator# 135778 Nagoya-shi
Japan Site Reference ID/Investigator# 126550 Niigata-shi
Japan Site Reference ID/Investigator# 126556 Nishinomiya-shi
Japan Site Reference ID/Investigator# 132108 Obu-shi
Japan Site Reference ID/Investigator# 133805 Okayama-shi
Japan Site Reference ID/Investigator# 133807 Okayama-shi
Japan Site Reference ID/Investigator# 129896 Omihachiman
Japan Site Reference ID/Investigator# 133795 Osaka-shi
Japan Site Reference ID/Investigator# 133801 Osaka-shi
Japan Site Reference ID/Investigator# 124802 Saga-shi
Japan Site Reference ID/Investigator# 124797 Saitama-shi
Japan Site Reference ID/Investigator# 124798 Saitama-shi
Japan Site Reference ID/Investigator# 133806 Saku-shi
Japan Site Reference ID/Investigator# 126954 Sapporo-shi
Japan Site Reference ID/Investigator# 128966 Sapporo-shi, Hokkaido
Japan Site Reference ID/Investigator# 124799 Shibukawa-shi
Japan Site Reference ID/Investigator# 133809 Shibukawa-shi
Japan Site Reference ID/Investigator# 132114 Shimotsuga-gun
Japan Site Reference ID/Investigator# 126961 Shimotsuke-shi
Japan Site Reference ID/Investigator# 126962 Shimotsuke-shi
Japan Site Reference ID/Investigator# 126956 Shizuoka-shi
Japan Site Reference ID/Investigator# 132113 Shizuoka-shi
Japan Site Reference ID/Investigator# 126559 Suita-shi
Japan Site Reference ID/Investigator# 124801 Tokyo
Japan Site Reference ID/Investigator# 124808 Tokyo
Japan Site Reference ID/Investigator# 124809 Tokyo
Japan Site Reference ID/Investigator# 126549 Tokyo
Japan Site Reference ID/Investigator# 126552 Tokyo
Japan Site Reference ID/Investigator# 126553 Tokyo
Japan Site Reference ID/Investigator# 126555 Tokyo
Japan Site Reference ID/Investigator# 126967 Tokyo
Japan Site Reference ID/Investigator# 128456 Tokyo
Japan Site Reference ID/Investigator# 124804 Toon-shi
Japan Site Reference ID/Investigator# 135038 Toyoake
Japan Site Reference ID/Investigator# 124810 Tsu-shi
Japan Site Reference ID/Investigator# 133810 Tsukuba-shi
Japan Site Reference ID/Investigator# 132109 Yamagata-shi
Japan Site Reference ID/Investigator# 132110 Yamaguchi-shi
Japan Site Reference ID/Investigator# 133812 Yatomi-shi
Japan Site Reference ID/Investigator# 126557 Yokohama-shi
Japan Site Reference ID/Investigator# 126558 Yokohama-shi
Japan Site Reference ID/Investigator# 133799 Yonago-shi

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events Include adverse events and adverse drug reactions stratified by patient background, concomitant drugs and concomitant therapy. From the first administration of palivizumab to 30 days after the last administration of palivizumab. Yes
Primary Frequency of Serious Adverse Events From the first administration of palivizumab to 30 days after the last administration of palivizumab Yes
Secondary Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV) From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
Secondary Total Number of RSV Hospitalization Days From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
Secondary Total RSV Hospitalizations in patients requiring respiratory support Respiratory support includes oxygen therapy, mechanical ventilation, membrane oxygenation, continuous positive airway pressure or Intensive Care Unit (ICU) admission. From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
Secondary Total Number of RSV Hospitalization days in subjects requiring respiratory support Respiratory support includes oxygen therapy, mechanical ventilation, membrane oxygenation, continuous positive airway pressure or ICU admission. From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
Secondary Rate of Hospitalization due to patient characteristics Patient Characteristics that are being considered are sex, race, age, family structure and medical history From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
Secondary Change in Lower Respiratory tract Infection (LRI) Score The LRI score is provided by the clinical investigator after assessment. From the first administration of palivizumab to 30 days after the last administration of palivizumab. No
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