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

NCT04112199 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-05-08

No results posted yet for this 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

Conditions

  • Ascites
  • Decompensated Cirrhosis

Interventions

DRUG

BIV201 continuous infusion

BIV201 continuous infusion with terlipressin for a total of two 28 day cycles. Initiate treatment at 3 mg per 24 hour period and titrate stepwise up to a maximum of 8 mg per 24 hour period based on tolerability and response.

Sponsors & Collaborators

  • BioVie Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Palumbo, MD · BioVie Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2023-05-08
Completion
2023-05-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112199 on ClinicalTrials.gov