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

NCT00656370 | Completed Phase 4 Results

• 1 other identifier: HZ2-07-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase

Outcome Measures

Primary Outcomes (1)

• The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)

  Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.

  Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1

Secondary Outcomes (5)

• Number of Participants Assessed for Safety Measures

  Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)

• Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution

  During infusion on Day 1

• Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites

  Before the infusion, during the infusion, after the infusion, and discharge (Day 1)

• Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference

  Before the infusion (Baseline) until discharge (Day 1)

• Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)

  End of infusion (Day 1)

Study Arms (2)

NS Infusion Group

EXPERIMENTAL

Normal Saline (NS) and Hylenex

Drug: recombinant human hyaluronidase

LR Infusion Group

EXPERIMENTAL

Lactated Ringer's (LR) and Hylenex

Drug: recombinant human hyaluronidase

Interventions

recombinant human hyaluronidase DRUG

150 Units in 1mL

Also known as: Hylenex

LR Infusion Group; NS Infusion Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halozyme Therapeutics: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

Results Point of Contact

• Title: Dimitrios Chondros, M.D., Chief Medical Officer
• Organization: Halozyme Therapeutics

dchondros@halozyme.com

858-794-8889

Study Officials

• Shanthini Daniel, M.D.

  Jasper Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 11, 2008
• Study Start: December 1, 2007
• Primary Completion: January 30, 2008
• Study Completion: January 30, 2008
• Last Updated: October 17, 2018
• Results First Posted: May 14, 2010

Record last verified: 2018-09

Locations

US (1)