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Recombinant Hyaluronidase in Out-of-Hospital Setting: The EASI Access Trial

NCT00386386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-03-13

No results posted yet for this study

Summary

The study's overarching aim is to determine whether Enzymatically Augmented Subcutaneous Infusion (EASI) can assist in out-of-hospital situations characterized by mismatch between need for, and ability to achieve, access to the vascular compartment. One mechanism for providing access to the vascular compartment, subcutaneous infusion, is facilitated by administration of hyaluronidase; the hyaluronidase hydrolyzes hyaluronan the major subcutaneous diffusion barrier. Hyaluronidase thus increases local dispersion and absorption of subcutaneously administered drugs and fluids.

The EASI Access study is intended to be the first out-of-hospital study assessing FDA-approved Chinese hamster ovary-derived recombinant hyaluronidase (the recombinant product is hereafter referred to by the shorter brand name, Hylenex). The EASI Access will test some fundamental principles and will facilitate design and implementation of follow-up investigations (e.g. extension of access to non-ALS providers). For example, we will attempt to show that EASI access is simple, effective, and has few or no downsides as compared to IV access.

Conditions

Interventions

OTHER

hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion

Above

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Stephen H Thomas, MD MPH · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-12-31
Completion
2007-12-31

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 NCT00386386 on ClinicalTrials.gov