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

Allergic Asthma Clinical Trial

Official title:

An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328886
• Other study ID #: CIGE025B1301E1
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2011
• Last updated: November 16, 2016
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Omalizumab
omalizumab lyophilized 150 mg injection

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Habikino city	Osaka
Japan	Novartis Investigative Site	Komae	Tokyo
Japan	Novartis Investigative Site	Ohbu	Aichi
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Shimotsuka-gun	Tochigi
Japan	Novartis Investigative Site	Sumida-ku	Tokyo
Japan	Novartis Investigative Site	Tenri	Nara
Japan	Novartis Investigative Site	Tsu	Mie
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	To explore the efficacy of omalizumab by use of asthma long-term control medications		Every 3 months for approximately 2 years	No
Secondary	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	No
Secondary	To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma		Every 3 months for approximately 2 years	No

External Links

•   Results for CIGE025B1301E1 from the Novartis Clinical Trials Website