Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

What Was Tested

The trial (phase 2) is built around Terlipressin.

It had three arms (groups): An Open-Label Safety Run-In Part (experimental), Single-blind Placebo-controlled Randomized period (placebo comparator) and An Open-Label Terlipressin Non-Responder Cohort (experimental).

The registry classes the interventions as drug.

More on the Plan

The study consists of: A. an Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by B. a Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and C. an Open-Label Terlipressin Non-Responder Cohort.

For those Cohorts where terlipressin will be administered combined with R2R01 (i.e., Cohorts 1, 2, 3, 4, and 6), the first R2R01 administration will commence immediately following the first terlipressin administration.

This study will be conducted across approximately 25 centers in EU, UK, US, and Canada.

The treatment duration is up to 14 days with a follow-up period of approximately 76 days.

Who Took Part

Enrollment: 95 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At least 18 years of age. Cirrhosis and ascites. Female patients as well as female partners of male patients must be willing to avoid pregnancy for the duration of the study (\>90 days).

The full record lists 7 inclusion and 25 exclusion criteria; among the exclusions: AKI stage 1; ACLF stage 3; model for end-stage liver disease (meld) score \>35.

How the Study Was Run

Design: randomized, sequential and single-blind.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In this single-blind Terlipressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-06-30 with completion listed for 2024-12.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs). Safety Evaluation Criteria - Change in Weight (time frame: Change from screening through Day 30). Safety Evaluation Criteria - Vital Signs - Respiration Rate (time frame: Change from screening through Day 30).

It also tracked 2 secondary outcomes, for example Mortality Rate and Liver Transplant Rates.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 95 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.