EUCTR2013-000056-18-DE
Active, not recruiting
Not Applicable
Safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to hay fever patients. A Phase IIa dose-escalation study.
BioTech Tools S.A.0 sitesFebruary 4, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Treatment of seasonal grass pollen rhinoconjunctivitis.
- Sponsor
- BioTech Tools S.A.
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated Informed Consent Form by a legally competent patient
- •Female or male patients aged 18–70 years
- •The patients are in good physical and mental health according to his/her medical history and vital signs
- •Non\-pregnant, non\-lactating females with adequate contraception (see Annex XX.3\)
- •Females unable to bear children must have signed the form for adequate contraceptive protection (see Annex XX.3\) (i.e. tubule ligation, hysterectomy, or post\-menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •oA medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) for the grass pollen season during at least the two previous years
- •oA positive skin prick test (wheal diameter \= 3 mm) to grass\-pollen mixture, histamine wheal \= 3 mm, NaCl control reaction \= 2 mm
- •oSpecific IgE against grass pollen (IgE \> 0\.7 kU/l)
- •oPatients treated with anti\-allergic medication for at least 2 years prior to enrolment
Exclusion Criteria
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Previous immunotherapy with grass allergens within the last 5 years,
- •Ongoing immunotherapy
- •Patients being in any relationship or dependence with the Sponsor and/ or Investigator
- •Inability to understand instructions/ study documents
- •Patients with a history of hypersensitivity to the excipients of investigational products
- •Patients with partly controlled or uncontrolled asthma
- •Chronic asthma or emphysema, particularly with a FEV 1 \<80% of the predicted value (ECSC)
- •Patients symptomatic to perennial inhalant allergens to which the subjects are regularly exposed.
- •Patients with a history of renal disease or chronic hepatic disease
Outcomes
Primary Outcomes
Not specified
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