EUCTR2011-004486-33-BE
Active, not recruiting
Phase 1
Safety, clinical tolerability and immunogenicity of gpASIT+TM administered subcutaneously to hay fever patients either alone or in presence of DnaK immunoregulating adjuvant. - not available
BioTech Tools S.A.0 sitesOctober 26, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BioTech Tools S.A.
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has given written informed consent
- •Age between 18 and 50 years
- •The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- •Male or non\-pregnant, non\-lactating female
- •Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post\-menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
- •o A positive skin prick test (wheal diameter \= 3 mm) to grass\-pollen mixture
- •o Specific IgE against grass pollen (IgE \> 0\.7 kU/l) \[using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213\)]
- •Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011\)
Exclusion Criteria
- •Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
- •Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
- •A history of hypersensitivity to the excipients of investigational products
- •Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
- •Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
- •Subjects with a VC \< 80% and a FEV1 \< 70% of predicted value at the screening visit.
- •Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period.
- •Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
- •Subjects with rhinitis medicamentosa, non\-specific rhinitis (to food dye, preservative agent…)
- •Subjects with a history of renal disease or chronic hepatic disease
Outcomes
Primary Outcomes
Not specified
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