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Prostacyclin Analogue
Treprostinil for Ischemia and Reperfusion Injury
Phase 1
Waitlist Available
Led By Abhinav Humar, M.D.
Research Sponsored by Abhinav Humar, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 4, 6, 12, 18, 24, 30, 36, 42, 48, 72, 96 and 120 hrs during therapy and approximately 0.5, 1, 2, 4, 6, 8, 12 and 24 hr post study drug termination
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a drug called Treprostinil given to liver transplant patients. The hypothesis is that the drug will help reduce the risk of complications and improve outcomes.
Eligible Conditions
- Ischemia Reperfusion Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 4, 6, 12, 18, 24, 30, 36, 42, 48, 72, 96 and 120 hrs during therapy and approximately 0.5, 1, 2, 4, 6, 8, 12 and 24 hr post study drug termination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 4, 6, 12, 18, 24, 30, 36, 42, 48, 72, 96 and 120 hrs during therapy and approximately 0.5, 1, 2, 4, 6, 8, 12 and 24 hr post study drug termination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serum ALT concentration after treprostinil treatment in liver transplant patients
Secondary outcome measures
Pharmacokinetics of treprostinil in liver transplant patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreprostinilExperimental Treatment1 Intervention
This is a single center, open-label, dose-escalation Phase I/II study of Treprostinil.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil
2021
Completed Phase 4
~180
Find a Location
Who is running the clinical trial?
Abhinav Humar, MDLead Sponsor
Abhinav Humar, M.D.Principal InvestigatorUniversity of Pittsburgh Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a liver transplant that did not work within the last 180 days.The liver comes from a donor with hepatitis C.You are getting a liver transplant from a living donor.You are getting a liver from a deceased donor.You have sudden and severe liver failure.You are allergic to prostaglandins, prostacyclin, or treprostinil.You are currently undergoing kidney dialysis.You are allergic to iodine.You have a serious heart condition and are taking certain heart medications.You cannot receive a donor liver that has been kept cold for less than 5 hours or more than 12 hours.You are taking any non-standard medications that could affect the study results.You are currently getting treated for portopulmonary hypertension.The donated liver has more than 40% of fat when tested with a biopsy.Your MELD score is over 40.You have HIV.You are currently taking methylene blue.You are having more than one organ transplant at the same time, except for the liver.You are taking a prostanoid for portopulmonary hypertension.
Research Study Groups:
This trial has the following groups:- Group 1: Treprostinil
Awards:
This trial has 1 awards, including:- 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.
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