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NCT04112199 · ClinicalTrials.gov registry record · Phase 2

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites

A Phase 2 study, sponsored by BioVie.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT04112199 is a Phase 2 study that was terminated before completion, run by BioVie. The registered enrollment target is 15 participants.

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The verdict

NCT04112199, a Phase 2 study, was terminated before completion, sponsored by BioVie.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients with refractory ascites secondary to decompensated cirrhosis

Interventions

  • DRUG BIV201 continuous infusion

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-06-17
Est. Completion 2023-05-08
Phase Phase 2

Sponsor

BioVie

6 total trials

What the Registry Record Tells You About NCT04112199

The ClinicalTrials.gov registry entry for NCT04112199 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioVie, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which BIV201 continuous infusion is the first listed.

NCT04112199 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04112199 about?

NCT04112199 is a clinical study titled "A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites". This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients with refractory ascites secondary to decompensated cirrhosis

What is the current status of trial NCT04112199?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-06-17. Estimated completion is 2023-05-08.

What interventions are being tested in trial NCT04112199?

The interventions under investigation include: BIV201 continuous infusion (DRUG).

Who is sponsoring clinical trial NCT04112199?

This trial is sponsored by BioVie, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.