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An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia

This ongoing study is for children with a bone growth condition called achondroplasia. It's designed to continue looking at a medicine called BMN 111, which was also studied in a previous trial. Children who took part in the earlier study (either BMN 111 or a placebo) might be able to join this one. The main goals are to understand how safe BMN 111 is and if it helps children with achondroplasia grow over a longer period, possibly until they reach their adult height. The medicine is given as a needle jab under the skin once a day. This is a "Phase 2" study, meaning researchers are still gathering more information about the medicine.

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Estado
Activo, no reclutando
Fase
FASE2
Patrocinador
BioMarin Pharmaceutical
Objetivo de inscripción
73
Inicio
12 Jun 2019
Estimación de finalización
01 May 2038

¿De qué trata este estudio?

This study is an important next step for children with a genetic condition called achondroplasia. Achondroplasia affects how bones grow, leading to shorter arms and legs. Researchers are testing a medicine named BMN 111, which previous studies have suggested might help with bone growth.

This specific study is an 'extension' of an earlier trial. This means that children who participated in the first study, whether they received BMN 111 or a placebo (a dummy treatment), may now have the chance to continue with BMN 111. The main idea is to see if BMN 111 is safe to use over a longer time and if it continues to help children grow taller until they've reached their full adult height.

By taking part, around 70 children will receive daily doses of BMN 111. The information gathered will help doctors and scientists understand more about how this medicine works and whether it could become a treatment option in the future. It's a way of continuing to learn about the medicine's long-term effects on growth and overall health.

Puntos clave

  • This is an extension study for children with achondroplasia.
  • It tests an experimental medicine called BMN 111 given daily by injection.
  • The study aims to check the long-term safety and effectiveness of BMN 111.
  • Participants must have completed a previous BMN 111 study.
  • The study will continue until children reach near-adult height.
  • Regular health checks and growth monitoring will be part of taking part.

¿Quién puede ser elegible?

To join this study, children must have already completed a previous study (called 111-206) where they received either the study medicine BMN 111 or a placebo.

Parents or guardians need to be willing to give their written permission for their child to take part. If the child is old enough to understand, they will also be asked to agree in writing. It's also important that both the child and their family are able to follow all the study instructions and attend appointments.

However, some reasons might mean a child can't join. This includes if they stopped the previous study early, if they have certain heart problems, or if they're already taking other specific medications that might interfere with the study medicine. Pregnant individuals or those planning to become pregnant cannot participate. The study team will review all health information to make sure it's safe for every child to take part.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. Did my child complete the previous BMN 111 study (111-206)?
  2. Are we able and willing to follow all study instructions and attend appointments?
  3. Is my child currently taking any blood pressure medicines or other specific drugs?
  4. Does my child have any serious heart conditions?
  5. Are we planning for pregnancy during the study period?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If a child joins this study, they will receive BMN 111 as a daily injection under the skin. The dose will depend on their weight and age, as decided during the previous study. The study lasts until each child reaches their estimated adult height, which means it could be several years.

During this time, there will be regular visits to the clinic where doctors will check their health, measure their growth, and possibly take blood or urine samples to see how the medicine is working and to monitor for any side effects. These check-ups are important to make sure the medicine is safe and effective. The exact number and frequency of visits will be explained by the study team, but they will be spread out over the long term.

Riesgos y beneficios potenciales

Taking part in this study could offer potential benefits, such as continued access to BMN 111, which may help with bone growth in achondroplasia. However, as with any medicine, there are potential risks, and BMN 111 might have side effects. The study team will closely monitor participants' health and well-being to identify and manage any issues. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (16)

  • Children's Hospital & Research Center Oakland
    Código postal verificado
    Oakland, United States
  • Harbor - UCLA Medical Center
    Código postal verificado
    Torrance, United States
  • Alfred I. duPont Hospital for Children
    Código postal verificado
    Wilmington, United States
  • Emory University
    Código postal verificado
    Decatur, United States
  • Ann Robert and H. Lurie Children's Hospital of Chicago
    Código postal verificado
    Chicago, Estados Unidos
  • Cincinnati Childrens Hospital
    Código postal verificado
    Cincinnati, Estados Unidos
  • Vanderbilt University Medical Center
    Código postal verificado
    Nashville, Estados Unidos
  • Baylor College of Medicine
    Código postal verificado
    Houston, Estados Unidos
  • Medical College of Wisconsin, Children's Hospital
    Código postal verificado
    Milwaukee, United States
  • The Children's Hospital at Westmead
    Código postal verificado
    Westmead, Australia
  • Murdoch Children's Research Institute
    Código postal verificado
    Parkville, Australia
  • Osaka University
    Código postal verificado
    Osaka, Japón

Preguntas comunes

What is achondroplasia?

Achondroplasia is a genetic condition that affects how bones grow, leading to shorter arms and legs.

What is BMN 111?

BMN 111 is an experimental medicine being tested to see if it can help improve bone growth in children with achondroplasia.

How is the medicine given?

BMN 111 is given as a daily injection (a small jab) under the skin.

¿Cuánto tiempo durará el estudio?

The study will last for many years, until your child reaches their full adult height.

Can my child stop taking part if they want to?

Yes, you and your child can decide to leave the study at any time, for any reason.

Cómo obtener más información

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

Discusión

Discusión comunitaria

Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.