Clinical Trial: Ragweed-SPIRE Follow-On Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment
Brief Summary: The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.
Detailed Summary:
Sponsor: Circassia Limited
Current Primary Outcome: Total Rhinoconjunctivitis Symptom Score [ Time Frame: Approximately 12 months after first dose in TR006 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rescue Medication Score [ Time Frame: Approximately 12 months after first dose in TR006 ]
- Patient Global Assessment [ Time Frame: Approximately 12 months after first dose in TR006 ]
- Skin Prick Test [ Time Frame: Approximately 12 months after first dose in TR006 ]
- Immunoglobulin E Test [ Time Frame: Approximately 12 months after first dose in TR006 ]
Original Secondary Outcome: Same as current
Information By: Circassia Limited
Dates:
Date Received: March 19, 2015
Date Started: April 2015
Date Completion:
Last Updated: March 22, 2016
Last Verified: March 2016
