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Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

NCT ID: NCT00219323

Last Updated: 2011-10-25

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

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-03-31

Brief Summary

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This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Omalizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Allergic asthma patients
* Inadequately controlled patients

Exclusion Criteria

* \- History of severe anaphylactoid or anaphylactic reactions
* Previous treatment with omalizumab
* History of cancer or cancer
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals Japan

Role: STUDY_CHAIR

Novartis Pharmaceuticals Japan

Locations

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This study is not being conducted in the United States

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CIGE025A1307

Identifier Type: -

Identifier Source: org_study_id