Trial Outcomes & Findings for Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE) (NCT NCT04460560)
NCT ID: NCT04460560
Last Updated: 2024-10-09
Results Overview
SCr will be collected daily, from Day 1 thru end of treatment. Complete response (CR) defined as ≥30% decrease in SCr with EOT SCr≤1.5, partial response (PR) as ≥30% decrease in SCr with EOT SCr\>1.5, and non-response (NR) as \<30% decrease in SCr.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
14 days or reversal of HRS-AKI, whichever occur first
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Prospective Terlipressin Group
Patients to be treated with open label terlipressin by infusion following an initial bolus dose of 0.5mg.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
Baseline characteristics by cohort
| Measure |
Prospective Terlipressin Group
n=50 Participants
Patients to be treated with open label terlipressin by infusion following an initial bolus dose of 0.5mg.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 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
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days or reversal of HRS-AKI, whichever occur firstPopulation: descriptive statistics were used only
SCr will be collected daily, from Day 1 thru end of treatment. Complete response (CR) defined as ≥30% decrease in SCr with EOT SCr≤1.5, partial response (PR) as ≥30% decrease in SCr with EOT SCr\>1.5, and non-response (NR) as \<30% decrease in SCr.
Outcome measures
| Measure |
Open-label Terlipressin
n=50 Participants
Terlipressin
|
|---|---|
|
Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered.
complete response
|
32 Participants
|
|
Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered.
partial response
|
8 Participants
|
|
Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered.
no response
|
10 Participants
|
Adverse Events
Open-Label Terlipressin
Serious events: 26 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Open-Label Terlipressin
n=50 participants at risk
All prospective patients receive open-label Terlipressin.
Terlipressin: For the first dose of terlipressin, each vial will be reconstituted with 5 mL of sterile 0.9% sodium chloride solution and administered intravenously as a bolus injection and given over 1 minute at a dose of 0.5 mg.
For continuous infusion, the dose of terlipressin is to be dissolved in 0.9% sodium chloride solution and infused with a pump
|
|---|---|
|
Hepatobiliary disorders
Liver failure
|
6.0%
3/50 • Number of events 3 • 2 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinomatosis
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Hepatobiliary disorders
worsening ascites
|
10.0%
5/50 • Number of events 5 • 2 months
|
|
Hepatobiliary disorders
Decompensated hepatic cirrhosis
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Nervous system disorders
Hypotension
|
6.0%
3/50 • Number of events 3 • 2 months
|
|
Renal and urinary disorders
AKI
|
18.0%
9/50 • Number of events 9 • 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Nervous system disorders
Altered Mental Status (including hepatic encephalopathy)
|
12.0%
6/50 • Number of events 6 • 2 months
|
|
Renal and urinary disorders
Electrolyte abnormality
|
4.0%
2/50 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • Number of events 3 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
General disorders
Multi Organ Failure
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
2.0%
1/50 • Number of events 1 • 2 months
|
|
Infections and infestations
Spontaneous Bacterial Peritonitis
|
4.0%
2/50 • Number of events 2 • 2 months
|
|
Hepatobiliary disorders
Hepatic hydrothorax
|
2.0%
1/50 • Number of events 1 • 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place