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

Respiratory Syncytial Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016690
• Other study ID #: P14-296
• 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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