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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). 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 |
What the finished NCT00386386 record still lists
NCT00386386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion is the first listed.
NCT00386386 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00386386's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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