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

Purpose

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.

Condition	Intervention	Phase
Allergic Asthma	Drug: Omalizumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC) [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: No ]
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)) [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: No ]
To explore the efficacy of omalizumab by use of asthma long-term control medications [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: No ]
To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%) [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: No ]
To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma [ Time Frame: Every 3 months for approximately 2 years ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	March 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Omalizumab	Drug: Omalizumab omalizumab lyophilized 150 mg injection

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328886

Locations

Japan
Novartis Investigative Site
Ohbu, Aichi, Japan, 474-0031
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 228-8522
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 245-8575
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 232-8555
Novartis Investigative Site
Tsu, Mie, Japan, 514-0125
Novartis Investigative Site
Tenri, Nara, Japan, 632-8552
Novartis Investigative Site
Habikino city, Osaka, Japan, 583-8588
Novartis Investigative Site
Shimotsuka-gun, Tochigi, Japan, 321-0293
Novartis Investigative Site
Fuchu, Tokyo, Japan, 183-8561
Novartis Investigative Site
Komae, Tokyo, Japan, 201-8601
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 158-0097
Novartis Investigative Site
Sumida-ku, Tokyo, Japan, 130-8587
Novartis Investigative Site
Chiba, Japan, 266-0007
Novartis Investigative Site
Fukuoka, Japan, 811-1394
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Gifu, Japan, 501-1194
Novartis Investigative Site
Tokyo, Japan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01328886 History of Changes
Other Study ID Numbers:	CIGE025B1301E1
Study First Received:	April 1, 2011
Last Updated:	March 29, 2013
Health Authority:	United States: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

omalizumab
allergic asthma
pediatric patients

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013