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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00325338 |
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Follow-up Study the Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in the EEC will be determined. Patients who previously completed two EEC portions of study Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before the 2005 ragweed season will be enrolled.
Condition | Intervention | Phase |
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Type I Hypersensitivity |
Biological: Ragweed MATAMPL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Follow-up Study to Evaluate the Sustained Clinical Efficacy of Ragweed MATA MPL (Allergy Therapeutics®) in Patients With Ragweed-Induced Seasonal Allergic Rhinitis Upon Re-Exposure to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Model, Approximately One Year After Pre-Seasonal Treatment in 2005 |
Estimated Enrollment: | 100 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of childbearing potential must be using one of the following acceptable birth control methods:
Exclusion Criteria:
Canada, Ontario | |
Allied Research International Inc. | |
Mississauga, Ontario, Canada, L4W 1N2 |
Principal Investigator: | Deepen Patel, MD | Allied Research International Inc. |
Study ID Numbers: | RagweedMATAMPL205, P2DP05007 |
Study First Received: | May 11, 2006 |
Last Updated: | September 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00325338 |
Health Authority: | Canada: Health Canada |
Allergy Specific Immunotherapy Ragweed Environmental Exposure Chamber |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |