A clinical trial to test if Ruconest causes immunological reactions in healthy volunteers who are allergic to cow's milk and/or rabbit.

A Phase I Study to assess in vitro and in vivo immunoreactivity of Ruconest in Subjects with cow's milk allergy (CMA) and/or rabbit allergy (RA).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20337

Enrollment

Registered

2012-06-15

Start date

2012-04-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's milk Allergy (CMA) Rabbit Allergy (RA)

Interventions

Ruconest (rhC1INH, recombinant human C1 inhibitor). Positive controls: Histamine-dihydrochloride 10 mg/ml (SPT) and histamine-BASE 0.01 mg/mL (ICT). Negative control: Saline.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent; 2. Males and females between 18 and 65 years old; 3. Medical records documenting clinical CMA and/or RA.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Severe dermographism; 3. Other concurrent disease or treatment that might interfere with the conduct of the study or the skin test response; 4. History or symptoms of significant psychiatric disease, including depression and schizophrenia or known or suspected addiction to drug and/or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
Negative predictive value of the Skin Prick Test is defined as the ratio of subjects without systemic symptoms of hypersensitivity following subcutaneous challenge over the number of subjects having tested negative for the SPT and ICT administration. Number and percent of subjects who experienced a positive skin reaction, defined as a mean wheal (mean of the horizontal and vertical diameter) that exceeds the negative control by at least 3 mm. A positive response for ICT was a mean erythema (mean of the horizontal and vertical diameter) that equals or exceeds the positive control. Treatment-emergent adverse events (TEAE) will be summarized by cohort of dilution; TEAEs are defined as adverse events (AEs) not present prior to the start of study product, or AEs present before study product that worsened after starting study product.	—

Measure

Time frame

Negative predictive value of the Skin Prick Test is defined as the ratio of subjects without systemic symptoms of hypersensitivity following subcutaneous challenge over the number of subjects having tested negative for the SPT and ICT administration. Number and percent of subjects who experienced a positive skin reaction, defined as a mean wheal (mean of the horizontal and vertical diameter) that exceeds the negative control by at least 3 mm. A positive response for ICT was a mean erythema (mean of the horizontal and vertical diameter) that equals or exceeds the positive control. Treatment-emergent adverse events (TEAE) will be summarized by cohort of dilution; TEAEs are defined as adverse events (AEs) not present prior to the start of study product, or AEs present before study product that worsened after starting study product.

—

Secondary

Measure	Time frame
Observation and description of local and/or systemic reactions following SPT, ICT and subcutaneous injection. Assessment of in vitro test to further evaluate the specific allergens involved,	—

Contacts

Public ContactAnnemarie Kleefstra

a.kleefstra@pharming.com+31 (0)71 5247425

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)