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Terlipressin continuous infusion

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Terlipressin continuous infusion is an investigational small molecule being studied for the treatment of cirrhosis, specifically for patients with cirrhosis and refractory ascites. It is administered as a continuous infusion and is currently in Phase 2 clinical development.

Who makes Terlipressin continuous infusion?

Terlipressin continuous infusion is being developed by BioVie Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol BIVI. The company is conducting clinical research to evaluate this treatment for patients with cirrhosis and refractory ascites.

What phase is Terlipressin continuous infusion in?

Terlipressin continuous infusion is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy in patients with cirrhosis and refractory ascites.

What clinical trials is Terlipressin continuous infusion in?

Terlipressin continuous infusion has been studied in one completed Phase 2 clinical trial with the identifier NCT03107091. This trial, titled 'Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites,' enrolled 6 participants in the United States and was not randomized or blinded.

Is Terlipressin continuous infusion the same as terlipressin?

Terlipressin continuous infusion refers to the method of administration of the drug terlipressin, which is given as a continuous infusion rather than as bolus doses. The clinical trial NCT03107091 specifically evaluated this continuous infusion approach in patients with cirrhosis and refractory ascites.