← Back to Search

BIV201 continuous infusion for Ascites

Phase 2
Waitlist Available
Research Sponsored by BioVie Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days following randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if adding the drug BIV201 to the standard care for ascites (diuretics and therapeutic paracentesis) can help reduce ascites and complications in adult patients with cirrhosis who haven't responded to the standard care.

Eligible Conditions
  • Ascites
  • Liver Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days following randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days following randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of complications, at least grade 2 severity
Secondary study objectives
Change in cumulative ascites

Side effects data

From 2010 Phase 4 trial • 1034 Patients • NCT00966355
1%
diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide
Somatostatin
Terlipressin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BIV201 plus Standard of CareExperimental Treatment1 Intervention
BIV201 continuous infusion - treatment for two 28 day cycles.
Group II: Standard of careActive Control1 Intervention
Per AASLD guidelines: diuretics and therapeutic paracentesis

Find a Location

Who is running the clinical trial?

BioVie Inc.Lead Sponsor
5 Previous Clinical Trials
519 Total Patients Enrolled
1 Trials studying Ascites
6 Patients Enrolled for Ascites
Giacomo Basadonna, MDStudy DirectorBioVie Inc.
Joseph Palumbo, MDStudy DirectorBioVie Inc.
1 Previous Clinical Trials
1,500 Total Patients Enrolled
~3 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top