Serelaxin To Lower Portal Pressure

What Was Tested

In this phase 2 trial, researchers set out to test Relaxin (Serelaxin).

This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

It had two arms (groups): Serelaxin (active comparator) and Placebo (placebo comparator).

IV infusion of serelaxin (RLX030) for 2 hours.

IV infusion of placebo (20mM sodium acetate pH5) matched to serelaxin for 2 hours.

The registry classes the interventions as drug.

More on the Plan

This study will investigate the effects of the investigational drug serelaxin (a recombinant form of the peptide human relaxin-2) on portal hypertension in patients with liver cirrhosis.

Who Took Part

The registry lists 15 actual participants took part.

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: Male or female adult subjects over 18 years of age. Able to provide written informed consent and able to understand and willing to comply with the requirements of the study. Clinical imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology. Evidence of portal hypertension either on imaging or previous endoscopy. Patients with large/grade 3 varices as identified by endoscopy within 6 months of screening must be in an endoscopic band ligation programme at the time of study entry.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: pregnancy or breast feeding; A history of variceal bleed within 1 month prior to visit 1; hepatocellular carcinoma or history of malignancy of any organ system (other than localized basal cell carcinoma of the skin) treated or untreated.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Relaxin (Serelaxin) group and the comparison group should start out alike.

The Relaxin (Serelaxin) group and the comparison group ran side by side rather than switching.

As a double-blind Relaxin (Serelaxin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-10-18 with completion listed for 2018-08-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in fasting hepatic venous pressure gradient (HVPG) (time frame: Baseline, after 2 hours).

It also tracked 8 secondary outcomes, for example Change from baseline in fasting hepatic venous pressure gradient (HVPG), Change from baseline in fasting hepatic blood flow, Change from baseline in cardiac index, Change from baseline in systemic vascular resistance index, Number of participants with adverse events and Change from baseline in blood biomarker measurements.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Relaxin (Serelaxin) compound page, all human trials.