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NCT04460560 · ClinicalTrials.gov registry record · Phase 3
Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
A Phase 3 study of Hepatorenal Syndrome, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 7
- Study locations
NCT04460560 is a Phase 3 study of Hepatorenal Syndrome that has completed, run by University of Pennsylvania. The registered enrollment target is 50 participants, below the 414-participant average among 5 other Hepatorenal Syndrome trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT04460560, a Phase 3 study of Hepatorenal Syndrome, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 7
- Study locations
Study Summary
Hepatorenal syndrome-acute kidney injury (HRS-AKI), a potentially reversible renal failure, is a serious, rapidly progressing, often fatal, complication of decompensated cirrhosis. Terlipressin is a synthetic vasopressin analogue that acts as a systemic vasoconstrictor via the vascular vasopressin V1 receptors. In HRS-AKI patients the strong V1 receptor-mediated vasoconstrictor activity of terlipressin, particularly in the splanchnic area, increases effective intravascular volume and mean arterial pressure (MAP), ameliorates renin-angiotensin-aldosterone system and sympathetic nervous system hyperactivity, and improves renal blood flow. The INFUSE trial will evaluate the use of continuous terlipressin infusion in patients on the liver transplant waiting list with HRS-AKI.
Conditions Studied
Interventions
- DRUG Terlipressin
Study Locations (7)
California
- California Pacific Medical Center - San Francisco
Georgia
- Piedmont Healthcare, Inc - Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- Mayo Clinic - Rochester
Pennsylvania
- University of Pennsylvania - Philadelphia
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Baylor Scott and White All Saints Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-12-11 |
| Est. Completion | 2023-12-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460560
The ClinicalTrials.gov registry entry for NCT04460560 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 414-participant average among 5 other Hepatorenal Syndrome trials with a reported enrollment target (88% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatorenal Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Terlipressin is the first listed.
NCT04460560 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04460560 about?
NCT04460560 is a clinical study titled "Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)". Hepatorenal syndrome-acute kidney injury (HRS-AKI), a potentially reversible renal failure, is a serious, rapidly progressing, often fatal, complication of decompensated cirrhosis. Terlipressin is a synthetic vasopressin analogue that acts as a systemic vasoconstrictor via the vascular vasopressin V...
What is the current status of trial NCT04460560?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2020-12-11. Estimated completion is 2023-12-27.
What conditions does trial NCT04460560 study?
This clinical trial studies the following conditions: Hepatorenal Syndrome.
What interventions are being tested in trial NCT04460560?
The interventions under investigation include: Terlipressin (DRUG).
Who is sponsoring clinical trial NCT04460560?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460560 being conducted?
This trial has 7 study locations across California, Georgia, Massachusetts, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.