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Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

NCT00807885 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-10-26

Study results available
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Summary

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

Conditions

Interventions

DRUG

hylenex-facilitated subcutaneous Lactated Ringer's infusion

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Sponsors & Collaborators

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • George Harb, MD, MPH · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807885 on ClinicalTrials.gov