Protocol Number; CIGE025F1401

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

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031200378

Enrollment

Registered

2021-03-01

Start date

2021-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who used Xolair in accordance with the instructions of package insert 2. Patients aged >= 12 years and < 18 years at the start of Xolair 3. 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

Exclusion criteria: Patients with a history of hypersensitivity to any of the Xolair ingredients

Design outcomes

Primary

Measure	Time frame
Proportions of patients with Adverse events (AEs), Serious AEs, AEs leading to discontinuation of Xolair treatment, Adverse drug reactions (ADRs), Serious ADRs, ADRs leading to discontinuation of Xolair treatment [ Time Frame: up to 24 weeks ]	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results