Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198419

Enrollment

Registered

2005-09-20

Start date

2004-03-31

Completion date

2004-03-31

Last updated

2013-03-14

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 10% hypersensitivity response was considered acceptable.

Interventions

DRUGVitrase

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Avoid disallowed meds throughout study

Exclusion criteria

* Known hypersensitivity to hyaluronidase and/or bee sting * Atopic individuals assessed by med history * Topical/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	hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase

Countries

United States

Outcome results

None listed

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