Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia

What Was Tested

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

This study is designed in two parts.

It had two arms (groups): RLX030 (experimental) and Placebo (placebo comparator).

In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts. In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours.

The registry classes the interventions as drug.

Who Took Part

The registry lists 3 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Written informed consent was obtained before any assessment was performed. Reassuring fetal testing (cardiotocography and biophysical profile).

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: severe hypertension (sbp ≥ 160 mmhg or dbp ≥ 110 mmhg) and /or those receiving anti-hypertensive treatment at time of randomization; clinically relevant electrocardiogram (ecg) abnormalities at screening excluding those abnormalities commonly seen in pregnancy according to the investigator; eclampsia during current pregnancy, vaginal bleeding present at screening, abruptio placentae, oligohydramnios.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Relaxin (Serelaxin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2013-05 with completion listed for 2014-08.

It ran at 5 sites in United States (4) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1). Change From Baseline in Mean Maternal Arterial Pressure (Part 1). Change From Baseline on Maternal Proteinuria (Part 1).

It also tracked 1 secondary outcome, for example Mean Number of Days Before Delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 3 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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