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NCT01116102 · ClinicalTrials.gov registry record · Phase 4

Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)

A Phase 4 study, sponsored by Baxter Healthcare Corporation.

Terminated
Registry status
Phase 4
Development phase
20
Enrollment target

NCT01116102: Clinical Trial Phase 4 study, sponsored by Baxter Healthcare Corporation.

NCT01116102 is a Phase 4 study that was terminated before completion, run by Baxter Healthcare Corporation. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01116102, a Phase 4 study, was terminated before completion, sponsored by Baxter Healthcare Corporation.

TERMINATED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.

Primary Outcome

Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion

Interventions

  • DRUG Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-05
Est. Completion 2010-06
Phase Phase 4
Baxter Healthcare Corporation

46 total trials

Why NCT01116102 stopped before completion

NCT01116102 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution is the first listed.

NCT01116102 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01116102 about?

NCT01116102 is a clinical study titled "Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)". The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lact...

What is the current status of trial NCT01116102?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2010-05. Estimated completion is 2010-06.

What interventions are being tested in trial NCT01116102?

The interventions under investigation include: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution (DRUG).

Who is sponsoring clinical trial NCT01116102?

This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01116102's enrollment target sits among peer trials

20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01116102, the US trial registry maintained by the National Library of Medicine. NCT01116102 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.