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Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
Plain-language guide to NCT02151383: phase 2 interventional trial of Relaxin (Serelaxin), 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02151383
- Phase
- phase 2
- Status
- terminated early
- Start
- 2014-09-05
- Completion (planned or actual)
- 2017-04-03
- Participants
- 12 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Acute Heart Failure
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Relaxin (Serelaxin).
It had 1 arm (groups): Serelaxin (experimental).
Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours.
The registry classes the interventions as drug.
More on the Plan
The study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (AHF) discontinued, following the results of the phase III study RELAX-AHF-2 (CRLX030A2301/NCT01870778) study in adult patients with AHF.
Who Took Part
12 actual participants took part.
It was open to people of any sex aged up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body weight ≥2.5 kg to ≤120 kg. Hospitalized in an intensive care unit or step-down unit with the following:. \- Signs and symptoms of acute heart failure of any etiology. Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.
The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction; single ventricle physiology; fixed pulmonary hypertension.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Relaxin (Serelaxin) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-09-05 with completion listed for 2017-04-03.
It ran at 10 sites in United States (5), Germany (3), Switzerland (1) and United Kingdom (1).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Relaxin (Serelaxin) in 12 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.
Our Notes on the Compound
Relaxin (Serelaxin): A pregnancy hormone that relaxes blood vessels; serelaxin is a recombinant form studied in acute heart failure.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.