- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361412
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy
October 6, 2011 updated by: Circassia Limited
An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002
The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L4W 1N2
- Cetero Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled in study TR002 but have not yet commenced dosing
Exclusion Criteria:
- None; no criteria additional to TR002 exclusion criteria are applicable to this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Intradermal injection 1x8 administrations, 2 weeks apart
|
Experimental: ToleroMune Ragweed 4
|
Intradermal administration 1x8 administrations, 2 weeks apart
|
Experimental: ToleroMune Ragweed Regimen 3
|
Intradermal administration 1x8 administrations, 2 weeks apart
|
Experimental: ToleroMune Ragweed Regimen 2
|
Intradermal administration 1x8 administrations, 2 weeks apart
|
Experimental: ToleroMune Ragweed Regimen 1
|
Intradermal administration 1x8 administrations, 2 weeks apart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of potential plasma biomarkers of response to peptide immunotherapy
Time Frame: 6 months after start of dosing
|
Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered.
The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatmen
|
6 months after start of dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
May 24, 2011
First Submitted That Met QC Criteria
May 25, 2011
First Posted (Estimate)
May 26, 2011
Study Record Updates
Last Update Posted (Estimate)
October 7, 2011
Last Update Submitted That Met QC Criteria
October 6, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR002A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ragweed Allergy
-
Circassia LimitedAdiga Life Sciences, Inc.Completed
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Circassia LimitedQuintiles, Inc.Completed
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Rambam Health Care CampusUnknownAllergy | Ambrosia | Ragweed
-
Fraunhofer-Institute of Toxicology and Experimental...RecruitingAllergic Rhinitis | Seasonal Allergic Rhinitis | Birch Pollen Allergy | Ragweed AllergyGermany
-
Stallergenes GreerQuintiles, Inc.CompletedRhinitis, Allergic, Seasonal | Ragweed Pollen AllergyHungary
-
Mati Therapeutics Inc.TerminatedSeasonal Allergic Conjunctivitis to RagweedCanada
-
University of RochesterNational Institute of Allergy and Infectious Diseases (NIAID)Not yet recruitingEgg Allergy | Food Allergy Peanut | Food Allergy in Infants | Allergy and Immunology | Peanut and Nut AllergyUnited States
-
Hong Kong Sanatorium & HospitalChinese University of Hong KongTerminatedAllergy to Fish | Allergy to Shrimp | Allergy to CrabHong Kong
Clinical Trials on ToleroMune Ragweed
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Circassia LimitedAdiga Life Sciences, Inc.Completed
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Circassia LimitedAdiga Life Sciences, Inc.; Pharm-Olam InternationalCompleted
-
Circassia LimitedAdiga Life Sciences, Inc.Completed
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Circassia LimitedAdiga Life Sciences, Inc.Completed
-
The University of Texas Medical Branch, GalvestonCompleted
-
Circassia LimitedAdiga Life Sciences, Inc.CompletedSeasonal Allergic RhinitisCanada
-
Circassia LimitedAdiga Life Sciences, Inc.CompletedAsthma | Seasonal Allergic RhinitisCanada