Status:
COMPLETED
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Halozyme Therapeutics
Conditions:
Dehydration
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), ...
Eligibility Criteria
Inclusion
- male or female, aged 18 to 60 years
- intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion
- agreeing to no fluid intake for 12 hours prior to start of study infusion
- vital signs within normal range or, if outside normal range, deemed not clinically significant
- metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant
- if female of child-bearing potential,negative serum pregnancy tests
- negative urine drug screens
- written informed consent for participation
Exclusion
- lower extremity edema
- lower extremity pathology that could interfere with study outcome
- history of cardiovascular disease
- rales on lung auscultation
- known allergy to hyaluronidase or other ingredient in the formulation of hylenex
- pregnancy or breast-feeding a child
- exposure to any experimental drug within 30 days prior to study participation
- previous participation in this study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00807885
Start Date
December 1 2008
End Date
January 1 2009
Last Update
October 26 2011
Active Locations (2)
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1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
2
MDS Pharma Services
Neptune City, New Jersey, United States, 07753