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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

Study 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
  • Cirrhosis

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of complications, at least grade 2 severity
Secondary outcome measures
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

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age requirement for participation in this experiment extend beyond seventy-five years?

"This medical study is looking to enrol patients aged 18 and up, but not exceeding 75 years."

Answered by AI

What is the current geographical spread of this clinical trial?

"The 10-site trial is currently operating in Richmond, Rochester and Los Angeles as well as additional sites. To reduce the travel burden associated with study participation, it can be beneficial to explore which location is closest to you first."

Answered by AI

Has the FDA authorized a prolonged infusion of BIV201?

"Due to the Phase 2 clinical trials that have been conducted, BIV201 continuous infusion can be deemed as moderately safe and was thus assigned a score of 2. No studies yet exist demonstrating its efficacy."

Answered by AI

To what medical ailments is BIV201 continuous infusion most commonly prescribed?

"BIV201 continuous infusion can be used to ameliorate liver transplant complications as well as choroid hemorrhage, portal hypertension, and hepatorenal syndrome."

Answered by AI

How many participants are currently enrolled in this experiment?

"As of the last update on October 15th 2022, this trial is not accepting any additional participants. However, there are presently 465 studies enrolling patients with ascites and 7 trials involving BIV201 continuous infusion that require volunteers."

Answered by AI

Are there any previously conducted tests involving BIV201 sustained administration?

"In 2014, the First Affiliated Hospital of Sumyetsan University conducted their first BIV201 continuous infusion study. 35 have been completed thus far and there are 7 active studies in progress; Richmond Virginia is home to a great many of these trials."

Answered by AI

What criteria must be fulfilled for someone to qualify as a participant in this research project?

"To be eligible for this trial, patients must have ascites and age between 18 to 75. This research is attempting to acquire a cohort of 30 participants."

Answered by AI

Is there presently an opportunity for participation in this medical investigation?

"Unfortunately, this trial is not recruiting new participants at the present moment. It was posted on June 17th 2021 and last edited October 15th 2022. However, if you're searching for other studies there are currently 465 trials looking to recruit patients with ascites and 7 clinical trials enrolling people that need BIV201 continuous infusion treatment."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Mayo Clinic: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
2021. "A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04112199.
~4 spots leftby Apr 2025
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