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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: Clinical Trial Phase 2 study, sponsored by BioVie.
NCT04112199 is a Phase 2 study that was terminated before completion, run by BioVie. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Incidence of complications, at least grade 2, during the 180 days following randomization
Interventions
- DRUG BIV201 continuous infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2023-05-08 |
| Phase | Phase 2 |
Why NCT04112199 stopped before completion
NCT04112199 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which BIV201 continuous infusion is the first listed.
NCT04112199 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04112199's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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