Trial Outcomes & Findings for Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites (NCT NCT03107091)

NCT ID: NCT03107091

Last Updated: 2021-07-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 28 day treatment period and 28 day post-treatment
• Results posted on: 2021-07-13

Participant Flow

Single site

Participant milestones

Measure	Terlipressin Acetate Continuous Infusion Continuous 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 Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Terlipressin Acetate Continuous Infusion Continuous 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 Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Overall Study Physician Decision	1

Baseline Characteristics

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Baseline characteristics by cohort

Measure	Terlipressin Acetate Continuous Infusion n=6 Participants Continuous 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 Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
MELD score	15 score on a scale n=5 Participants
Serum creatinine	1.30 mg/dL n=5 Participants
Child-Pugh score	9 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: 28 day treatment period and 28 day post-treatment

Population: Enrolled

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

Outcome measures

Measure	Terlipressin Acetate Continuous Infusion n=6 Participants Continuous infusion of terlipressin
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites TEAE	6 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites Serious AE	4 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites Related TEAE	3 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites Serious related TEAE	0 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites TEAE leading to drug withdrawal	3 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites Grade 3 TEAE	4 Participants
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites Fatal TEAE	0 Participants

PRIMARY outcome

Timeframe: 7 day treatment

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

Outcome measures

Measure	Terlipressin Acetate Continuous Infusion n=6 Participants Continuous infusion of terlipressin
Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites Terlipressin	2.48 ng/mL Interval 1.67 to 3.23
Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites 8-lysine vasopressin	0.089 ng/mL Interval 0.07 to 0.138

SECONDARY outcome

Timeframe: 28 day post-treatment

Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed

Outcome measures

Measure	Terlipressin Acetate Continuous Infusion n=6 Participants Continuous infusion of terlipressin
Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin Percent change in volume ascites removed during 28d treatment period versus 28d pre-treatment period	-66.5 percent change Interval -100.0 to -35.0
Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin Percent change in LVP interval during treatment versus before treatment	128 percent change Interval 0.0 to 414.0

Adverse Events

Terlipressin Acetate Continuous Infusion

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Terlipressin Acetate Continuous Infusion n=6 participants at risk Continuous 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 Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Hepatobiliary disorders Hepatic encephalopathy	33.3% 2/6 • Number of events 2 • 56 days
Infections and infestations Bacteremia	16.7% 1/6 • Number of events 1 • 56 days
Gastrointestinal disorders Ruptured umbilical hernia	16.7% 1/6 • Number of events 1 • 56 days
Gastrointestinal disorders Partial bowel obstruction	16.7% 1/6 • Number of events 1 • 56 days

Other adverse events

Measure	Terlipressin Acetate Continuous Infusion n=6 participants at risk Continuous 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 Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Cardiac disorders tachycardia	16.7% 1/6 • Number of events 1 • 56 days
Gastrointestinal disorders diarrhea	16.7% 1/6 • Number of events 1 • 56 days
General disorders Energy increased	16.7% 1/6 • Number of events 1 • 56 days
Metabolism and nutrition disorders decreased appetitie	16.7% 1/6 • Number of events 1 • 56 days
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 1 • 56 days

Additional Information

Penelope Markham

BioVie

Phone: 17035989972

Email: pmarkham@biovieinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60