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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00656370
First received: April 3, 2008
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: recombinant human hyaluronidase
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • The Subject's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS). [ Time Frame: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes. ] [ Designated as safety issue: No ]
    Subject's self-assessment of discomfort at the infusion site by means of a validated visual analogue scale (VAS) with a range of 0 mm (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of NS versus LR, each following an SC slow-push injection of 150 U Hylenex.


Secondary Outcome Measures:
  • Safety Assessment of 15 Participants Who Were Included in the Safety Data Set. [ Time Frame: Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left ] [ Designated as safety issue: No ]
    Safety outcome measures included adverse events (AEs), physical examinations, and vital signs.

  • Average Infusion Flow Rate (mL/hr) Derived From the Time to Infuse up to 500mL of Solution [ Time Frame: During infusion ] [ Designated as safety issue: No ]
  • Change in Circumference of the Thigh at the Infusion Site [ Time Frame: Before the infusion, during the infusion, after the infusion, and discharge ] [ Designated as safety issue: No ]
  • Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference. [ Time Frame: Before the infusion until discharge ] [ Designated as safety issue: No ]
  • Subject's Global Preference for Infusion (Left vs. Right Thigh) [ Time Frame: End of infusion ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NS Infusion Group
Normal Saline (NS) and Hylenex
Drug: recombinant human hyaluronidase
150 Units in 1mL
Other Name: Hylenex
Experimental: LR Infusion Group
Lactated Ringer's (LR) and Hylenex
Drug: recombinant human hyaluronidase
150 Units in 1mL
Other Name: Hylenex

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656370

Locations
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Halozyme Therapeutics
Baxter Healthcare Corporation
Investigators
Principal Investigator: Shanthini Daniel, M.D. Jasper Clinic, Inc.
  More Information

No publications provided

Responsible Party: Jonathan Leff, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00656370     History of Changes
Other Study ID Numbers: HZ2-07-03
Study First Received: April 3, 2008
Results First Received: February 18, 2010
Last Updated: April 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
Hylenex
subcutaneous infusion
hyaluronidase
rHuPH20
recombinant human hyaluronidase

ClinicalTrials.gov processed this record on October 22, 2014