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Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) (INFUSE-NSLR)
This study has been completed.
Sponsors and Collaborators: Halozyme Therapeutics
Baxter Healthcare Corporation
Information provided by: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00656370
  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 NS solution to LR solution. Each subject will receive 500 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 IV

Drug Information available for: Hyaluronidase Ringer's lactate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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: Before the start of infusion, middle of infusion, end of infusion, and discharge from the clinic ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessment including adverse events, physical examinations, and vital signs [ Time Frame: Before infusion, during infusion, post infusion, and discharge ] [ Designated as safety issue: Yes ]
  • Average infusion flow rate (mL/hr) derived from teh 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
NS, LR: Experimental
Normal Saline (NS) and Hylenex and lactated Ringer's (LR) and Hylenex
Drug: recombinant human hyaluronidase
1mL

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 (BP, HR, RR) within normal range.
  5. Metabolic panel within normal range.
  6. A negative urine or serum pregnancy test.
  7. Signed, written 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
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

Responsible Party: Halozyme Therapeutics ( Richard Yocum, M.D. )
Study ID Numbers: HZ2-07-03
Study First Received: April 3, 2008
Last Updated: April 11, 2008
ClinicalTrials.gov Identifier: NCT00656370  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009