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NCT00311519 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Healthy, sponsored by Halozyme Therapeutics.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target
1
Study location

NCT00311519 is a Phase 4 study of Healthy that has completed, run by Halozyme Therapeutics. The registered enrollment target is 50 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00311519, a Phase 4 study of Healthy, has completed, sponsored by Halozyme Therapeutics.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Hylenex

Study Locations (1)

California

  • West Coast Clinical Trials - Long Beach

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2005-11
Est. Completion 2006-01
Phase Phase 4

Sponsor

Halozyme Therapeutics

31 total trials

What the Registry Record Tells You About NCT00311519

The ClinicalTrials.gov registry entry for NCT00311519 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Hylenex is the first listed.

NCT00311519 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00311519 about?

NCT00311519 is a clinical study titled "A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects". 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 enzym...

What is the current status of trial NCT00311519?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2005-11. Estimated completion is 2006-01.

What conditions does trial NCT00311519 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00311519?

The interventions under investigation include: Hylenex (DRUG).

Who is sponsoring clinical trial NCT00311519?

This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00311519 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.