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NCT00386386 · ClinicalTrials.gov registry record · Phase 3
Recombinant Hyaluronidase in Out-of-Hospital Setting: The EASI Access Trial
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00386386: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00386386 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386386, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
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.
Interventions
- OTHER hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-05 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00386386
The ClinicalTrials.gov registry entry for NCT00386386 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion is the first listed.
NCT00386386 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00386386 about?
NCT00386386 is a clinical study titled "Recombinant Hyaluronidase in Out-of-Hospital Setting: The EASI Access Trial". 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...
What is the current status of trial NCT00386386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2007-05. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00386386?
The interventions under investigation include: hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion (OTHER).
Who is sponsoring clinical trial NCT00386386?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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