ong-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Childre

• Conditions: Allergic Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003536-12-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-16
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer.
•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; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance.
•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.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified