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Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

NCT00500539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2011-06-02

Study results available
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Summary

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Conditions

Interventions

DRUG

omalizumab

The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Tanox

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Jose Bardelas, MD · Allergy and Asthma center of North Carolina, PA, High Point, NC 27262

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Argentina
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00500539 on ClinicalTrials.gov