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

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

ClinicalTrials.gov Identifier: NCT04648930

Novartis Reference Number: CIGE025F1401

Last Update: Dec 27, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Allergic Rhinitis
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jan 27, 2021
Completion date 
Jan 31, 2023
Gender 
All
Age(s)
12 Years - 17 Years (Child)

Interventions

Drug
Xolair
There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

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:

1. Patients with a history of hypersensitivity to any of the Xolair ingredients

Study Locations

Japan
Novartis Investigative Site
Recruiting
Inazawa, 495-0002
Aichi
Japan
Novartis Investigative Site
Recruiting
Ichikawa-city, 272-0143
Chiba
Japan
Novartis Investigative Site
Recruiting
Inzai, 270-1337
Chiba
Japan
Novartis Investigative Site
Recruiting
Chikusei City, 308-0031
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Sagamihara-city, 252-0392
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Chiyoda, 102-0093
Tokyo
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 813 0043
-
Japan
Novartis Investigative Site
Recruiting
Kumamoto, 860-0814
-
Japan
Novartis Investigative Site
Recruiting
Kyoto, 604-0837
-
Japan
Novartis Investigative Site
Recruiting
Kyoto, 604-8152
-
Japan
Novartis Investigative Site
Recruiting
Nagasaki, 850-0057
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 544-0033
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan
Novartis Investigative Site
Recruiting
Saitama, 331-0802
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]