Europas førende søgning efter kliniske forsøg

Lucerastat

Clinical trials are investigating Lucerastat in adults with Fabry disease. The main goal is to see how safe and tolerable Lucerastat is over the long term. These studies help researchers understand whether it can be used in people living with this rare condition.

Indholdsfortegnelse

Oversigt over forsøget

Det registrerede forsøg med Lucerastat undersøger voksne med Fabry sygdom og ser på langtids-sikkerhed og tolerabilitet.[1] Det betyder, at forskerne vil finde ud af, hvordan behandlingen tåles over tid, og om der opstår nye helbredsproblemer undervejs.[1]

Hvem forsøget er for

Forsøget er for voksne personer med Fabry sygdom.[1] De tilgængelige forsøgsdata giver ikke flere detaljer om øvrige krav til deltagelse, såsom bestemte symptomer eller tidligere behandling.[1]

Forsøgsfase og studiedesign

Studiet er et interventionsstudie, hvilket betyder, at deltagerne får en aktiv behandling, og forskerne følger resultatet.[1] Det er et fase 3-forsøg, som normalt bruges til at samle mere viden om sikkerhed og mulig effekt i en større gruppe mennesker.[1]

Hvad forskerne måler

Det vigtigste resultatmål er treatment-emergent adverse events og serious adverse events.[1] På almindeligt dansk betyder det, at forskerne registrerer bivirkninger og andre helbredsproblemer, som begynder efter, at behandlingen er startet, og især om nogle af dem er alvorlige.[1]

Status og deltagerantal

Forsøget er angivet som Authorised og har en planlagt eller registreret deltagelse på 103 personer.[1] Den registrerede behandling i studiet er oral Lucerastat, som gives som medicin gennem munden.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03737214 Phase 3 Fabry disease Authorised 103

FAQ

  • What is being studied in Lucerastat clinical trials? The trial is studying the long-term safety and tolerability of Lucerastat in adults with Fabry disease. Researchers are mainly looking for treatment-emergent side effects, including serious ones.
  • Who can take part in the trial? The study is for adult subjects with Fabry disease. The trial data do not list other detailed entry rules here.
  • What phase is the Lucerastat trial? This is a Phase 3 trial. Phase 3 studies usually look at how well a treatment works and how safe it is in a larger group of people.
  • What condition is the trial focused on? The trial focuses on Fabry disease. This is the condition being studied in the enrolled participants.
  • What is the main outcome the researchers measure? The main outcome is treatment-emergent adverse events and serious adverse events. In simple terms, researchers track any new health problems that start after treatment begins.

Igangværende kliniske forsøg for Lucerastat

  • Undersøgelse af hvor sikkert lægemidlet lucerastat er ved langvarig behandling af voksne med Fabry sygdom

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Østrig Belgien Frankrig Tyskland Norge Polen +1

Ordliste

  • Fabry disease: A rare condition that is the focus of this trial. The study is being done in adults who have this disease.
  • Phase 3: A later stage of a clinical trial. It usually studies a treatment in a larger group to learn more about safety and possible benefit.
  • Interventional study: A trial where researchers give a treatment and then observe what happens.
  • Long-term safety: How safe a treatment is when used over a longer period of time.
  • Tolerability: How well people can take a treatment without it causing too much trouble or discomfort.
  • Treatment-emergent adverse events: Health problems that start or get worse after the treatment begins.
  • Serious adverse events: Severe health problems that can be dangerous or need urgent medical care.
  • Enrollment: The number of people planned or included in a study.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-hvor-sikkert-laegemidlet-lucerastat-er-ved-langvarig-behandling-af-voksne-med-fabry-sygdom/