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NCT00656370 · ClinicalTrials.gov registry record · Phase 4
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
A Phase 4 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00656370: Completed Phase 4 study, sponsored by Halozyme Therapeutics.
NCT00656370 is a Phase 4 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656370, a Phase 4 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex. In Stage 2, the comparison will be NS solution and buffered NS solution.
Primary Outcome
Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.
Interventions
- DRUG recombinant human hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-01-30 |
| Phase | Phase 4 |
What the finished NCT00656370 record still lists
NCT00656370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which recombinant human hyaluronidase is the first listed.
NCT00656370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656370 about?
NCT00656370 is a clinical study titled "Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)". Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (L...
What is the current status of trial NCT00656370?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2007-12. Estimated completion is 2008-01-30.
What interventions are being tested in trial NCT00656370?
The interventions under investigation include: recombinant human hyaluronidase (DRUG).
Who is sponsoring clinical trial NCT00656370?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656370's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 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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