Clinical trial NCT00656370: Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Normal Saline and Lactated Ringer's (INFUSE-NSLR) Study: A Phase IV, Double-Blind, Randomized Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) in Volunteer Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Hylenex
subcutaneous infusion
hyaluronidase
rHuPH20
recombinant human hyaluronidase
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-04-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.

In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.

Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.

Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)
timeFrame: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1
Secondary outcomes:
measure: Number of Participants Assessed for Safety Measures
timeFrame: Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)
measure: Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution
timeFrame: During infusion on Day 1
measure: Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites
timeFrame: Before the infusion, during the infusion, after the infusion, and discharge (Day 1)
measure: Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference
timeFrame: Before the infusion (Baseline) until discharge (Day 1)
measure: Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)
timeFrame: End of infusion (Day 1)
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic
state: Michigan
Study officials:
affiliation: Jasper Clinic, Inc.
name: Shanthini Daniel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: