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ToleroMune Ragweed Follow up Study

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Cetero Research, San Antonio
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01448603
First received: October 6, 2011
Last updated: May 16, 2012
Last verified: May 2012

October 6, 2011
May 16, 2012
October 2011
March 2012   (final data collection date for primary outcome measure)
Total Rhinoconjunctivitis Symptom Score [ Time Frame: 48-54 weeks after the start of treatment in TR002 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01448603 on ClinicalTrials.gov Archive Site
  • Total nasal and non-nasal symptom scores [ Time Frame: 48-54 weeks after the start of treatment in TR002 ] [ Designated as safety issue: No ]
  • Change in Immunoglobulin A (IgA) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
  • Change in Immunoglobulin E (IgE) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
  • Change in Immunoglobulin G4 (IgG4) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 50-56 weeks after the start of treatment in TR002 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
ToleroMune Ragweed Follow up Study
An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.

Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%

The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.

Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).

  • Ragweed Allergy
  • Rhinoconjunctivitis
  • Biological: Placebo
    No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
  • Biological: ToleroMune Ragweed
    No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
  • Placebo
    Subjects previously randomised to placebo in TR002
    Intervention: Biological: Placebo
  • ToleroMune Ragweed Regimen 1
    Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002
    Intervention: Biological: ToleroMune Ragweed
  • ToleroMune Ragweed Regimen 2
    Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002
    Intervention: Biological: ToleroMune Ragweed
  • ToleroMune Ragweed regimen 3
    Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002
    Intervention: Biological: ToleroMune Ragweed
  • ToleroMune Ragweed regimen 4
    Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002
    Intervention: Biological: ToleroMune Ragweed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Previously randomised into study TR002 and completed all treatment visits and the PTC.

Exclusion Criteria

  • History of asthma (a diagnosis of asthma in childhood may be allowed).
  • Subjects with an FEV1 <70% of predicted.
  • Subjects being treated with beta-blockers.
  • Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01448603
TR002B
No
Circassia Limited
Circassia Limited
  • Adiga Life Sciences
  • Cetero Research, San Antonio
Principal Investigator: Peter Couroux, MD Cetero Research, San Antonio
Circassia Limited
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP