A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects - Full Text View

Sponsored by:	Halozyme Therapeutics
Information provided by:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT00311519

Purpose

The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer’s is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme.

The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.

Condition	Intervention	Phase
Healthy	Drug: Hylenex	Phase IV

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIB Double Blind, Randomized, Placebo-Controlled, Dose-Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:

Average infusion flow rate (mL/hr) derived from the time to infuse 400 mL of lactated ringers

Secondary Outcome Measures:

Average SC infusion rate of flow (mL/hr) derived from time required to drain 400 mL from the 500 mL infusate bag, fluid and tubing AND for the arm circumference to return to baseline
Flow rate determined by weight of infusate bag, fluid and tubing at specified timepoints
For SC infusions, change in arm circumference in three locations in the vicinity of the site of infusion
For SC infusions, time from the beginning of infusion until arm circumference returns to baseline
Subject assessment of local discomfort by placing a mark on a 0 100 mm visual analogue scale (VAS) anchored by no discomfort and worst possible discomfort
Local edema assessed by the Investigator on a 0-4 scale
Leakage of fluid at angiocatheter site assessed by the Investigator on a 0-4 scale, prior to infusion, at mid-infusion, at end of infusion, and (for SC infusions), when arm circumference returns to baseline
Subject’s global rank-ordered preference for infusion
Investigator’s global rank-ordered preference for infusion
Photographic images of the SC infusion sites
Safety and tolerability, based on adverse events and PE including vital signs

Estimated Enrollment:	50
Study Start Date:	November 2005
Estimated Study Completion Date:	January 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males or females aged 18 to 60 years, inclusive
Agreement that there will be no fluid intake for 12 hours prior to the start of the study infusion (except sips of water to take necessary medications)
Vital signs (BP, HR, RR) within normal range
Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of infusion
Adequate venous access in at least one forearm
A negative pregnancy test (if female of child-bearing potential) within 7 days of infusion
Decision-making capacity
Signed, written IRB-approved informed consent

Exclusion Criteria:

Extremity edema
Upper extremity pathology that could interfere with study outcome (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.)
History of cardiovascular disease
Rales on lung auscultation
Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX
Known allergy to bee or vespid venom
Known coagulopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311519

Locations

United States, California
West Coast Clinical Trials
Long Beach, California, United States, 90806-2325

Sponsors and Collaborators

Halozyme Therapeutics

Investigators

Principal Investigator:

Javier T Quesada, OD

West Coast Clinical Trials

More Information

No publications provided

Study ID Numbers:	HZ2-05-04
Study First Received:	April 4, 2006
Last Updated:	April 5, 2006
ClinicalTrials.gov Identifier:	NCT00311519 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:

Subcutaneous hydration
Hylenex
Hyaluronidase

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009