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Terlipressin continuous infusion

Phase 2

Cirrhosis | Small molecule | Gastrointestinal |BioVie Inc.|Trials Updated: Jul 13, 2021

Terlipressin continuous infusion target and mechanism

Molecular targetAVPR1A, AVPR1B, AVPR2
Target classBinding Agent
ModalitySmall molecule

Also known as Terlipressin acetate continuous infusion

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Terlipressin continuous infusion clinical trials

Terlipressin continuous infusion · 1 trial · 2 indications

Phase 2 1
NCT03107091Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory AscitesCirrhosis
COMPLETED6 Analytics
PHASE2COMPLETED
Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
CirrhosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
28 day treatment period and 28 day post-treatment

Rate of treatment emergent adverse events assessed by physical examination and laboratory safety

Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
7 day treatment

Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)

Secondary Endpoints

Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin
28 day post-treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Terlipressin acetate continuous infusionEXPERIMENTALContinuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days

Interventions

NameTypeDescription
Terlipressin acetate continuous infusionDRUGLow-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days Exclusion Criteria: * Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carci...

Countries:United States
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Frequently asked questions about Terlipressin continuous infusion

What is terlipressin continuous infusion?

Terlipressin continuous infusion is an investigational small molecule being developed by BioVie Inc. (BIVI) for cirrhosis. It is a continuous infusion formulation of terlipressin, also known as terlipressin acetate continuous infusion. The drug is in Phase 2 clinical development and has been studied in patients with cirrhosis and refractory ascites.

What is terlipressin continuous infusion used for in cirrhosis?

Terlipressin continuous infusion is being studied for use in patients with cirrhosis, specifically those with refractory ascites. It is not approved for this use and remains investigational. The Phase 2 trial evaluated its use in adults with cirrhosis and ascites hepatic.

What does terlipressin continuous infusion target?

Terlipressin continuous infusion targets the vasopressin receptors AVPR1A, AVPR1B, and AVPR2. It is classified as a binding agent. By acting on these receptors, it is thought to affect vascular tone and fluid regulation, which is relevant in cirrhosis with ascites.

Who is developing terlipressin continuous infusion?

Terlipressin continuous infusion is being developed by BioVie Inc., which trades under the ticker BIVI. BioVie is the sponsor of the clinical program investigating this formulation for cirrhosis.

What phase is terlipressin continuous infusion in?

Terlipressin continuous infusion is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 trial has been completed.

What clinical trials is terlipressin continuous infusion in?

Terlipressin continuous infusion has been studied in one completed Phase 2 trial, NCT03107091, titled Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites. The trial enrolled 6 participants in the United States and was uncontrolled, non-randomized, and not double-blind.

Is terlipressin continuous infusion the same as terlipressin acetate continuous infusion?

Yes, terlipressin continuous infusion is also known as terlipressin acetate continuous infusion. Both names refer to the same investigational product being developed by BioVie Inc. for cirrhosis.