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An extension study to CIGE025B1301 to evaluate the long-term safety, tolerability and efficacy of omalizumab in Japanese children

An extension study to CIGE025B1301 to evaluate the long-term safety, tolerability and efficacy of omalizumab in Japanese children

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221414
Enrollment
35
Registered
2011-03-25
Start date
2011-03-25
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 asthma

Interventions

investigational material(s) Generic name etc : Omalizumab(Genetical Recombination) INN of investigational material : Omalizumab(Genetical Recombination) Therapeutic category code : 449 Other antiall

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.

Exclusion criteria

Exclusion criteria: 1.Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer. 2.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are -women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner -women whose partners have been sterilized by vasectomy or other means -using a highly effective method of birth control agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance 3.With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study 4.Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026