Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

Phase 3

Completed

• Conditions: Allergic Asthma
• Interventions: Drug: Omalizumab

• Registration Number: NCT01328886
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• 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.

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omalizumab	Omalizumab	-

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs	Every 3 months for approximately 2 years

Secondary Outcome Measures

Name	Time	Method
To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu))	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by use of asthma long-term control medications	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)	Every 3 months for approximately 2 years
To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma	Every 3 months for approximately 2 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Gifu, Japan