Phase 4 N=25 Randomized Quadruple-blind Treatment

Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00656370 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2010

Primary outcome: Primary: The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS) — 20.0; 9.4 mm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: recombinant human hyaluronidase (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Halozyme Therapeutics
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)	20.0; 9.4	—
SECONDARY Number of Participants Assessed for Safety Measures	15	—
SECONDARY Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution	384.1; 395.8	0.93
SECONDARY Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites	5.2; 5.3	0.67
SECONDARY Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference	147.3; 123.5	—
SECONDARY Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)	0; 15	—

Summary

Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex. In Stage 2, the comparison will be NS solution and buffered NS solution.

Eligibility Criteria

Inclusion Criteria

Male or female, 18 to 60 years of age.
Intact normal skin without in the areas intended for infusion.
No fluid intake for 12 hours prior to the start of the study infusion.
Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.
Metabolic panel within normal range.
A negative urine or serum pregnancy test.
Signed, written Institutional Review Board (IRB)-approved informed consent.

Exclusion Criteria

Lower extremity edema.
Lower extremity pathology that could interfere with study outcome.
Rales on lung auscultation.
History of cardiovascular disease.
Allergy to hyaluronidase.
Allergy to bee or vespid venom.
Pregnancy or breast-feeding woman.
Use of any investigational drug or device within 30 days of enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00656370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.