What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis, particularly those aimed at improving renal function in hepatorenal syndrome (HRS) and acute kidney injury (AKI), include vasoactive agents like terlipressin and renal protective agents. Terlipressin, a vasopressin analog, is known to cause ischemic complications, although it has a lower side effect profile compared to other vasopressin analogs. Side effects of terlipressin can include abdominal pain, diarrhea, and cardiovascular issues such as bradycardia and hypertension. Other treatments like albumin infusions are generally well-tolerated but can occasionally cause allergic reactions and fluid overload. It is important to monitor patients closely for these potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for liver cirrhosis that are similar to the ones being studied in the OCE-205 trial include terlipressin and albumin infusion. Terlipressin, a vasopressin analog, has been shown to be effective in reversing hepatorenal syndrome with a lower profile of side effects compared to other vasopressin analogs like ornipressin. Additionally, tolvaptan has been used in liver cirrhosis patients with hepatic edema, although it is primarily a vasopressin receptor antagonist rather than a direct vasoactive agent. These treatments aim to improve renal function and manage complications associated with liver cirrhosis.

What other types of research exist?

Promising alternatives to OCE-205 for treating HRS-AKI in liver cirrhosis patients include terlipressin and norepinephrine, which have been studied for their efficacy in improving renal function in septic shock and other conditions. Additionally, agents like FOY (Gabexate mesilate), SOD (Superoxide Dismutase), and PEG-SOD (Polyethylene Glycol-modified SOD) have shown renal protective effects in ischemic acute renal failure models and may offer potential benefits in HRS-AKI.

← Back to Search

Other

OCE-205 for Hepatorenal Syndrome with Acute Kidney Injury

Phase 2

Waitlist Available

Research Sponsored by Ocelot Bio, Inc

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 up to 5 years

Summary

This trial is testing OCE-205, a new drug, to help patients with severe liver disease that has caused their kidneys to fail. The drug is given through an IV to see if it can improve kidney function.

Who is the study for?

This trial is for adults with decompensated cirrhosis and ascites who developed Hepatorenal Syndrome-Acute Kidney Injury. They must have tried diuretic withdrawal and plasma volume expansion without improvement in kidney function. Participants need to agree to contraception use, not be pregnant or breastfeeding, and not have severe additional health issues like uncontrolled infections or recent malignancies.

What is being tested?

The study tests OCE-205's safety and effectiveness at different doses for treating Hepatorenal Syndrome-Acute Kidney Injury in cirrhosis with ascites patients. It involves intravenous infusions of either OCE-205 or a placebo until the primary endpoint is met or discontinuation criteria are reached.

What are the potential side effects?

While specific side effects of OCE-205 aren't listed, common ones from similar treatments may include reactions at the infusion site, changes in blood pressure, potential kidney function alterations, allergic responses, gastrointestinal symptoms like nausea or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: OCE-205 Cohort 5Experimental Treatment1 Intervention

OCE-205, 50 µg/hr, intravenous infusion

Group II: OCE-205 Cohort 4Experimental Treatment1 Intervention

OCE-205, 30 µg/hr, intravenous infusion

Group III: OCE-205 Cohort 3Experimental Treatment1 Intervention

OCE-205, 15 µg/hr, intravenous infusion

Group IV: OCE-205 Cohort 2Experimental Treatment1 Intervention

OCE-205, 8 µg/hr, intravenous infusion

Group V: OCE-205 Cohort 1Placebo Group1 Intervention

Placebo, intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OCE-205

2022

Completed Phase 2

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cirrhosis include diuretics like spironolactone and furosemide, which help reduce fluid accumulation by promoting sodium and water excretion. Vasoactive agents such as terlipressin and midodrine are used to improve renal function in HRS-AKI by constricting blood vessels and increasing blood pressure, thereby enhancing renal perfusion. Albumin infusions are also employed to maintain plasma volume and improve circulatory function. These treatments are crucial for liver cirrhosis patients as they address complications like ascites and HRS-AKI, which can significantly impact morbidity and mortality.

Comparative efficacy of pharmacological strategies for management of type 1 hepatorenal syndrome: a systematic review and network meta-analysis.