NCT00198458CompletedPhase 1
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Hypersensitivity
Study Overview
Brief Summary
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Agreed to avoid disallowed meds
Exclusion Criteria
- •Known hypersensitivity to hyaluronidase and/or bee sting
- •Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
- •Atopic individuals assessed by medical history
- •Topical/inhaled/systemic corticosteroids within 30 days
- •Concurrent use of antihistamines or anti-inflammatory during study
- •Active or chronic disease likely to affect immune function
- •History of alcohol/drug abuse within 6 months
Arms & Interventions
Vitrase
Experimental
A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control.
Intervention: Vitrase (Drug)
Outcomes
Primary Outcomes
Hypersensitivity
Time Frame: 1-2 days
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)Drug HypersensitivityNCT00198419Bausch & Lomb Incorporated65
Not yet recruiting
Not Applicable
A controlled in vitro hypersensitivity assessment in subjects previously treated whit the combination of GLPG3067 and GLPG2222, or the combination of GLPG3067, GLPG222 and GLPG2737 using Lymphocyte Transformation Test.Skin reaction (e.g. rash)10014982NL-OMON45940Galapagos N.V.2
Completed
Phase 4
Aquacel Hypersensitivity Dressing in TJAsContact Allergic DermatitisAdverse Skin ReactionNCT06011629Rush University Medical Center457
Not yet recruiting
Not Applicable
Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reactioIn this study, we investigate drug hypersensitivity using a definitive diagnosis algorithm (modified Mirakian R. Clin Exp Allergy. 2009 Jan39:43-61.) to examinations of a suspected adverse drug reaction.JPRN-UMIN000026980Department of Pediatrics, Ehime University Hospital40
Completed
Phase 1
A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)HypersensitivityAnaphylaxisNCT02028065Merck Sharp & Dohme LLC382