Surveillance of Synagis in Korean Pediatric Patients

NCT01537198 | Completed Results

• 1 other identifier: P13-203
• Study Type: observational
• Target: 618
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.

Conditions

Respiratory Syncytial Virus Infection

Keywords

Postmarketing Drug Surveillance

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)

  An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.

  From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis

Study Arms (1)

Pediatric Participants at High Risk of RSV

Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

General hospital

You may qualify if:

• Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:
• Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
• Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
• Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
• Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

You may not qualify if:

• Contraindications according to the approved label.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• SoRa Lee, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: February 23, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 10, 2015
• Results First Posted: July 10, 2015

Record last verified: 2015-06