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Vasopressin analogue
Terlipressin for Hepatorenal Syndrome (INFUSE Trial)
Phase 3
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On liver transplant wait list or liver transplant eligible with anticipation of being placed on the liver transplant wait list
Cirrhosis and ascites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days or reversal of hrs-aki, whichever occur first
Awards & highlights
INFUSE Trial Summary
This trial will evaluate the use of terlipressin, a synthetic vasopressin analogue, in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI), a potentially reversible renal failure.
Who is the study for?
This trial is for adults with cirrhosis and ascites on the liver transplant waitlist or eligible for it, who have Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) without significant improvement in kidney function after specific treatments. Excluded are those with severe renal impairment, certain cardiovascular diseases, recent exposure to nephrotoxic agents, uncontrolled infections or sepsis, advanced cancer affecting the liver, and women who are pregnant.Check my eligibility
What is being tested?
The INFUSE trial tests continuous infusion of terlipressin in patients awaiting a liver transplant with HRS-AKI. Terlipressin is a drug that constricts blood vessels to increase blood pressure and improve kidney function by targeting specific receptors in the vascular system.See study design
What are the potential side effects?
Terlipressin may cause side effects such as abdominal cramps, diarrhea, headache, nausea or vomiting due to its vasoconstrictive properties. It can also potentially lead to serious cardiovascular events given its systemic vasoconstriction action.
INFUSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on the liver transplant wait list or eligible to be on it soon.
Select...
I have cirrhosis and fluid buildup in my abdomen.
Select...
I am 18 years old or older.
INFUSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days or reversal of hrs-aki, whichever occur first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days or reversal of hrs-aki, whichever occur first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,038 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidney function has declined significantly, with a higher level of creatinine in your blood compared to your usual levels.I do not have an ongoing severe infection or sepsis.You are expected to live for less than 7 days.You are allergic or sensitive to terlipressin.My kidney function hasn't improved despite treatment.I am on the liver transplant wait list or eligible to be on it soon.I have had a TIPS procedure within the last 30 days.I do not have severe heart or blood vessel problems.I have acute liver injury not caused by alcohol.I haven't used kidney-damaging drugs or had certain scans in the last 4 weeks.I have signs of a blockage in my urinary system or kidney damage.I haven't used strong blood pressure drugs for 3 days before starting terlipressin.My kidney test shows signs of damage or disease.I have cirrhosis and fluid buildup in my abdomen.I am currently experiencing shock.My liver failure is severe, classified as grade 3.I am on or might need kidney replacement therapy soon.I am 18 years old or older.Your MELD score is 35 or higher.Your blood test shows a creatinine level higher than 5.0 mg/dL. You may still join the study if the sponsor agrees.I am not pregnant and have a negative pregnancy test.My liver cancer is advanced, and doctors expect I have less than 6 months to live.I am willing to stop taking midodrine and octreotide before joining.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment and enrollment still active for this research project?
"The study is still recruiting patients, according to the information found on clinicaltrials.gov. This trial was first posted on December 11th, 2020 and updated April 4th, 2022."
Answered by AI
How many people are qualified to participate in this clinical trial?
"That is correct. The clinical trial, which began recruiting on December 11th 2020, as indicated by the website clinicaltrials.gov, is still looking for 50 individuals to participate. These participants will be drawn from 7 different locations."
Answered by AI
In how many sites is this trial currently being conducted?
"To reduce the burden of travel for participants, this trial is being run out of 7 sites that are close to major metropolitan areas. These include Philadelphia, Nashville and Boston among other locations."
Answered by AI
Will this treatment option have any negative effects on patients?
"This Phase 3 trial has provided some data to support efficacy and multiple rounds of safety data, so our team at Power rates the safety a 3."
Answered by AI
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