Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    30
  • sponsor
    Novartis Pharmaceuticals
Updated on 24 May 2021

Summary

This is a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged 12 years and < 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.

Description

The observation period will last for up to 24 weeks, with Day 1 defined as the start date of Xolair treatment. It should be noted that, because the duration of Xolair treatment depends on the pollen dispersal situation and other factors, patients who complete or discontinue Xolair treatment before the visit at 24 weeks after the start of treatment will be followed up until the date of last dose of Xolair + 30 days, and the results will be recorded in the CRF.

Details
Condition Allergic Rhinitis
Treatment Xolair
Clinical Study IdentifierNCT04648930
SponsorNovartis Pharmaceuticals
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who used Xolair in accordance with the instructions of package insert
Patients aged 12 years and < 18 years at the start of Xolair
Patients who used Xolair for the following indication
Indication: seasonal allergic rhinitis (only patients with severe to most
severe symptoms whose symptoms were inadequately controlled despite to
conventional therapies) 4. Patients having provided written consent to
participate in this study before the start of Xolair in the relevant pollen
season, in person and from their legally acceptable representative (legal
representative)

Exclusion Criteria

Patients with a history of hypersensitivity to any of the Xolair ingredients
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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