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

Primary Purpose

Allergic Asthma

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Omalizumab

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring omalizumab, allergic asthma, pediatric patients

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

Outcomes

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

Secondary Outcome Measures

To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)

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))

To explore the efficacy of omalizumab by use of asthma long-term control medications

To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)

To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma

Full Information

NCT ID

NCT01328886

First Posted

April 1, 2011

Last Updated

November 16, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01328886

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Asthma

Keywords

omalizumab, allergic asthma, pediatric patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Intervention Description

omalizumab lyophilized 150 mg injection

Primary Outcome Measure Information:

Title

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