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NCT04112199
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
Phase 2 trial testing BIV201 continuous infusion in Ascites in 15 participants. Terminated before completion.
8 May 2023
Quick facts
| Lead sponsor | BioVie Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 17 June 2021 |
| Primary completion | 8 May 2023 |
| Estimated completion | 8 May 2023 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- BIV201 continuous infusion — full drug profile →
Conditions studied
- Ascites — all drugs for Ascites →
- Decompensated Cirrhosis — all drugs for Decompensated Cirrhosis →
Sponsor
BioVie Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Ascites or Decompensated Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and efficacy of continuous infusion terlipressin (BIV201): A phase 2 trial in patients with decompensated cirrhosis and refractory ascites.
Bajaj JS, Weinberg EM, Reddy KR, Keaveny AP, et al · · 2025 · cited 5× · PMID 40272365 · DOI 10.1097/lvt.0000000000000623
Verify or expand the search:
- PubMed search for NCT04112199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ascites
Currently open trials in the same condition.
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- NCT07435701 — Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites · Phase 1, PHASE2 · recruiting
- NCT06594562 — Free Fluid Detection With Telementored eFAST · NA · recruiting
- NCT07023042 — Kinesio-Taping vs. Usual Care for Malignant Bowel Obstruction With Ascites · NA · recruiting
- NCT06658080 — Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer · recruiting
Other BioVie Inc. trials
Trials by the same sponsor.
- NCT06757010 — A Study of NE3107 in Early Parkinson's · Phase 2 · recruiting
- NCT05083260 — NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa · Phase 1, PHASE2 · completed
- NCT04669028 — A Phase 3 Study of NE3107 in Probable Alzheimer's Disease · Phase 3 · completed
- NCT03107091 — Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04112199 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioVie Inc.
- Last refreshed: 8 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04112199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing