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Effectiveness and Safety of Omalizumab in Children With Allergic Asthma. | Clinical Trials | Clareo Health

COMPLETED

Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

A Retrospective Multicenter Study for Assessment of the Effectiveness and Safety of Omalizumab in Children With Allergic Asthma in a Real-world Setting in China

NCT05424523•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.

Detailed Description

This non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice. This study was designed to use secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -\<12 years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction.

Eligibility

Age

6 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged between 6 -\<12 years
•Diagnosed with allergic asthma and could be treated using omalizumab. Comorbidities included allergic rhinitis, atopic dermatitis, nasal polyp, chronic urticaria, and food allergy
•Received omalizumab during the identification period
•Had at least one documented follow-up data after omalizumab treatment
•Provided informed consent if required by ethics committee (EC) of hospital

Exclusion Criteria

•Current participation in a clinical trial of any investigational treatment

Locations (1)

Novartis Investigative Site

East Hanover, New Jersey, United States

Key Dates

Start Date

February 25, 2021

Primary Completion Date

June 28, 2021

Completion Date

June 28, 2021

Last Updated

July 5, 2022

Enrollment

200

ACTUAL participants

Conditions

Allergic Asthma

Interventions

Omalizumab

DRUG

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RECRUITINGPHASE3

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Allergic Asthma

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ENROLLING_BY_INVITATIONEARLY_PHASE1

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NCT01536522

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

Inclusion Criteria

Exclusion Criteria

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)

Asthma Inflammation Research

Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis

Tyrosine Allergoid Paediatric and Adult Study

Trial of JYB1904 in Patients With Allergic Asthma