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

NCT ID: NCT01328886

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Allergic Asthma

Keywords

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omalizumab allergic asthma pediatric patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omalizumab

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

omalizumab lyophilized 150 mg injection

Interventions

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Omalizumab

omalizumab lyophilized 150 mg injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ohbu, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Chiba, Chiba, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Gifu, Gifu, Japan

Site Status

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Tsu, Mie-ken, Japan

Site Status

Novartis Investigative Site

Tenri, Nara, Japan

Site Status

Novartis Investigative Site

Habikino, Osaka, Japan

Site Status

Novartis Investigative Site

Shimotsuka-gun, Tochigi, Japan

Site Status

Novartis Investigative Site

Fuchū, Tokyo, Japan

Site Status

Novartis Investigative Site

Komae, Tokyo, Japan

Site Status

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Sumida-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Odajima H, Ebisawa M, Nagakura T, Fujisawa T, Akasawa A, Ito K, Doi S, Yamaguchi K, Katsunuma T, Kurihara K, Teramoto T, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int. 2017 Jan;66(1):106-115. doi: 10.1016/j.alit.2016.06.004. Epub 2016 Aug 6.

Reference Type DERIVED
PMID: 27507228 (View on PubMed)

Other Identifiers

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CIGE025B1301E1

Identifier Type: -

Identifier Source: org_study_id