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Mecasermin Rinfabate

Clinical trials are studying Mecasermin Rinfabate in extremely premature babies with chronic lung disease. These studies look at whether it can help lower severe bronchopulmonary dysplasia, a serious lung problem, or death by 36 weeks after birth. The main focus is safety and efficacy compared with usual care.

Table of Contents

Trial Overview

The available trial is studying Mecasermin Rinfabate in babies with chronic lung disease, also called CLD.[1] The study is testing whether the treatment can lower the burden of lung disease compared with normally prescribed care.[1]

Who Is Being Studied

This trial is focused on extremely premature babies, a group at high risk for breathing problems after birth.[1] The trial data do not list more detailed entry rules, so the main target population is the newborn group described in the study title and summary.[1]

What the Trials Measure

The main endpoint is the incidence of severe BPD or death by 36 weeks of postmenstrual age, which is the age counted from the mother’s last menstrual period.[1] The study uses a grading system for BPD that separates babies into no BPD, mild BPD, moderate BPD, and severe BPD based on oxygen need and breathing support.[1]

In simple terms, the trial is checking whether fewer babies in the Mecasermin Rinfabate group reach the most serious lung outcome or die before the time point being measured.[1]

Trial Design and Phase

This is an interventional study, which means researchers assign a treatment and compare outcomes between groups.[1] It is a Phase 2 trial, so it is an early study that helps researchers learn more about whether the treatment may work and how it performs in a clinical setting.[1]

The trial status is listed as Authorised, and the planned enrollment is 317 participants.[1]

Main Trial Details

The trial identified as NCT03253263 is titled as a study of an experimental drug for chronic lung disease against normally prescribed care in extremely premature babies.[1] The brief summary says the study aims to reduce the burden of CLD by lowering the rate of severe BPD at 36 weeks (±3 days) PMA or death at or before that age, whichever happens first.[1]

The intervention is listed as Mecasermin Rinfabate given intravenously, and the dose field shows 0 micrograms per kilogram in the source data.[1] The comparison group is described as the SNC group, meaning standard care.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03253263 Phase 2 Chronic Lung Disease Authorised 317

FAQ

  • What condition is being studied in Mecasermin Rinfabate trials? The trial data focus on chronic lung disease in extremely premature babies. The main outcome is severe bronchopulmonary dysplasia, also called BPD, or death by 36 weeks after birth.
  • Who can participate in these trials? The study is for extremely premature babies. The trial data do not give more detailed eligibility rules, but the target group is clearly newborns at high risk for lung problems.
  • What phase is the Mecasermin Rinfabate trial? The trial is Phase 2. This means it is an early study that helps researchers learn more about safety and whether the treatment may work.
  • What is the trial comparing Mecasermin Rinfabate against? It is being compared with normally prescribed care, also called standard of care. The study looks at whether the trial treatment lowers the burden of chronic lung disease more than usual treatment alone.
  • What result is the study measuring? The main result is the number of babies who have severe BPD or die by 36 weeks after birth. The study also uses a grading system that separates no BPD, mild, moderate, and severe BPD.

Ongoing Clinical Trials on Mecasermin Rinfabate

  • Study on Mecasermin Rinfabate for Preventing Chronic Lung Disease in Extremely Premature Babies

    Recruiting

    1 1
    Investigated drugs:
    Finland Germany Ireland Italy The Netherlands Portugal +1

Glossary

  • Chronic lung disease: A long-lasting lung problem. In this trial, it is the main condition being studied in very premature babies.
  • Extremely premature babies: Babies born much earlier than expected. They are at higher risk for breathing and lung problems.
  • Bronchopulmonary dysplasia (BPD): A lung condition seen in premature babies who need breathing support or oxygen for a long time.
  • Severe BPD: The most serious level of BPD in the trial grading system. It can mean a baby still needs a lot of oxygen or breathing support at 36 weeks after birth.
  • Standard of care: The usual treatment or routine care that patients normally receive outside the trial.
  • Phase 2: An early stage of clinical research that looks more closely at safety and whether the treatment may help.
  • Interventional study: A study where researchers give a treatment and compare outcomes with another group.
  • Enrollment: The number of people planned for or included in a trial.
  • Postmenstrual age (PMA): The age of a baby measured from the first day of the mother's last period, counted through birth and after birth.
  • Positive pressure ventilation: Breathing support that helps push air into the lungs.

References