Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198458

Enrollment

Registered

2005-09-20

Start date

2004-07-31

Completion date

2004-09-30

Last updated

2013-03-18

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

Conditions

Drug Hypersensitivity

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.

Interventions

DRUGVitrase

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hypersensitivity	1-2 days	Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026