A clinical trial to test if Ruconest causes immunological reactions in healthy volunteers who are allergic to cow's milk and/or rabbit.
Completed
- Conditions
- Cow's milk Allergy (CMA)Rabbit Allergy (RA)
- Registration Number
- NL-OMON20337
- Lead Sponsor
- Pharming Technologies BV (Performer: University Medical Center Utrecht)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Signed written informed consent;
2. Males and females between 18 and 65 years old;
Exclusion Criteria
1. Pregnancy or breastfeeding;
2. Severe dermographism;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method egative predictive value of the Skin Prick Test is defined<br>as the ratio of subjects without systemic symptoms of <br>hypersensitivity following subcutaneous challenge over the <br>number of subjects having tested negative for the SPT and <br>ICT administration.<br><br>Number and percent of subjects who experienced a positive <br>skin reaction, defined as a mean wheal (mean of the <br>horizontal and vertical diameter) that exceeds the negative <br>control by at least 3 mm. A positive response for ICT was a <br>mean erythema (mean of the horizontal and vertical <br>diameter) that equals or exceeds the positive control.<br><br>Treatment-emergent adverse events (TEAE) will be<br>summarized by cohort of dilution; TEAEs are defined as <br>adverse events (AEs) not present prior to the start of study <br>product, or AEs present before study product that worsened <br>after starting study product.
- Secondary Outcome Measures
Name Time Method Observation and description of local and/or systemic<br>reactions following SPT, ICT and subcutaneous injection.<br><br>Assessment of in vitro test to further evaluate the specific <br>allergens involved,