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Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

NCT00555971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-03

Study results available
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Summary

This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several weeks later. One month after desensitization, the final visit will occur in the GCRC.

We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced reaction.

Conditions

  • Aspirin Sensitivity

Interventions

DRUG

Omalizumab

Subjects randomized to Omalizumab prior to aspirin desensitization

DRUG

placebo

Subjects randomized to Placebo prior to aspirin desensitization

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • David Lang

    lead OTHER

Principal Investigators

  • David M. Lang, M.D. · The Cleveland Clinic, Department of Allergy and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555971 on ClinicalTrials.gov