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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Novartis
Study ID
NCT00500539
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2007
Status verified
May 2011
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
155 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period [ Time Frame: 16 weeks after last dose ]

Locations (26)

FacilityCityStateZIPSite coordinators
Allergy & Immunology Associates, LtdScottsdaleArizonaAZ 85251-
California Allergy and Asthma Medical GroupPalmdaleCaliforniaCA 93551-
Allergy Associates Medical Group, Inc,San DiegoCaliforniaCA 92120-
Bensch Research AssociatesStocktonCaliforniaCA 95207-
1st Allergy and Clinical Research CenterCentennialColoradoCO 80112-
Innovative Research of West Florida, Inc.LargoFloridaFL 33770-
Georgia PollenAlbanyGeorgiaGA 31707-
Kansas City Allergy & AsthmaOverland ParkKansas66210-
Asthma and Allergy Specialists, PAMinneapolisMinnesotaMN 55402-
: The Clinical Research Center, LLCSt LouisMissouriMO 63141-
Allergy, Asthma and Clinical ImmunologyBrickNew JerseyNJ 08724-
Asthma & Allergy Research of NJ, Inc.Mount LaurelNew JerseyNJ 08054-
Nassau Chest Pysicians, PCMassapequaNew YorkNY 11758-
Allergy and Asthma Center of NC, PAHigh PointNorth CarolinaNC 27262-
Allergy Center at BrookstoneColumbusOhioOH 31904-
Toledo Center for Clinical ResearchSylvaniaOhioOH 43650-
Asthma and Allergy CenterToledoOhioOH 43617-
The Corvallis Clinic, PCCorvallisOregonOR 97330-
Allergy, Asthma & Dermatology Research CenterLake OswegoOregonOR97037-
Clinical Research Institute of Southern Oregon, PCMedfordOregonOR 97504-
Allergy & Asthma Specialists, PCBlue BellPennsylvaniaPA 19422-
Asthma Allergy & Pulmonary Associates, PCPhiladelphiaPennsylvaniaPA 19107-
AAPRI Clinical Research InstituteProvidenceRhode IslandRI 02906-
North Texas Institute for Clinical TrialsFort WorthTexasTX 76132-
Allergy and Asthma AssociatesHoustonTexasTX 77054-
Clinical Trials of North HoustonHoustonTexasTX 77070-

Find similar trials in Scottsdale, AZ

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Allergy & Immunology Associates, Ltd· Scottsdale, AZCalifornia Allergy and Asthma Medical Group· Palmdale, CAAllergy Associates Medical Group, Inc· San Diego, CABensch Research Associates· Stockton, CA1st Allergy and Clinical Research Center· Centennial, COInnovative Research of West Florida, Inc.· Largo, FL

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