Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

Completed · Phase 4

Conditions studied: Dehydration

In brief

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), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

Key facts

Study ID

NCT00807885

Run by

Baxter Healthcare Corporation

People needed

100

Starts

2008-12-01

Expected to finish

2009-01-01

Last updated by the study team

2011-10-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services — Lincoln, Nebraska, United States
• MDS Pharma Services — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.