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Ativo, mas não recrutandoFASE2, FASE3INTERVENCIONISTA

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

This study is an extension to see how safe and well-tolerated a new inhaled medicine, Treprostinil Palmitil (TPIP), is when used over a longer period. It's designed for people who have Pulmonary Arterial Hypertension (PAH) and have already taken part in previous studies of TPIP. The main goal is to check for any long-term side effects or problems. This type of research helps doctors understand if new treatments can be used safely for a long time. Participants will continue to receive either TPIP or a dummy treatment (placebo), and their health will be monitored closely.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2, FASE3
Patrocinador
Insmed Incorporated
Meta de inscrição
91
Iniciar
07 Mar 2023
Conclusão estimada
31 Dez 2026
Hipertensão Arterial Pulmonar

Sobre o que é este estudo?

This research is an extension study for a medicine called Treprostinil Palmitil, which is given as an inhaled powder. It's for people who have a serious lung condition called Pulmonary Arterial Hypertension (PAH). PAH makes the blood vessels in the lungs narrow, making it hard for the heart to pump blood, which can lead to breathlessness and tiredness. The main aim of this particular study is to keep a close eye on the safety of TPIP when people use it over a longer time. We want to understand if there are any long-term effects, good or bad, and how well people tolerate the treatment when it's used for an extended period. This is really important before a new medicine can be widely used.

This study isn't looking for new participants to start the treatment for the first time. Instead, it's open to people who have already completed other studies involving TPIP for PAH. By continuing to follow these participants, researchers can gather more information about the medicine's long-term safety and how well it helps manage PAH symptoms over time. This helps build a full picture of the treatment's benefits and any potential risks.

Knowing how safe a medicine is over a long time is crucial. It helps doctors make informed decisions about prescribing treatments and helps patients understand what to expect. This study is a vital step in the process of thoroughly testing new medicines to make sure they are as safe and effective as possible for people living with PAH.

Pontos principais

  • This study prolongs previous research on an inhaled medicine for PAH.
  • It focuses on the long-term safety and tolerability of Treprostinil Palmitil (TPIP).
  • Only people who completed earlier TPIP studies for PAH can join.
  • Participants will continue to receive either TPIP or a placebo.
  • Your health will be closely monitored throughout the study period.

Quem pode ser elegível?

This study is for people who have already taken part in previous studies of an inhaled medicine called Treprostinil Palmitil (TPIP) for their Pulmonary Arterial Hypertension (PAH).

To join, you must have completed your last visit in one of the specific earlier TPIP studies. If a long time has passed since your last visit in those studies (more than 30 days), you might need some new health checks to ensure you're still suitable for this extension study.

You cannot join if you've started certain other strong PAH medicines (like injected forms of prostacyclin) since your last study. If you've developed new serious heart problems, blood clots in your lungs, active liver disease, new cancers (except for fully treated skin or cervical cancer), or severe recent COVID-19, you also won't be able to take part. You also can't be taking part in any other drug or device trial.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Did you complete an earlier study testing Treprostinil Palmitil (TPIP) for PAH?
  2. Have you started other strong injected pulmonary hypertension medicines recently?
  3. Have you developed any new serious heart problems?
  4. Have you had a new diagnosis of cancer (excluding treated skin or cervical cancer)?
  5. Are you currently involved in another medical research study?
  6. Do you currently have severe COVID-19 or were recently hospitalised for it?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

This study is an extension, so you would have already taken part in an earlier study of TPIP. The exact details of visits and tests will depend on how long it has been since your last study visit, but generally, you will continue to receive either the study medicine (TPIP) or a dummy treatment (placebo) that you may have been on previously. You will have regular appointments where doctors will check your general health, measure your breathing, perform heart checks, and take blood samples. They will also ask about any side effects you might be experiencing. The overall length of time you take part is not specified but will be for a longer period to assess the medicine's safety over time.

Riscos e benefícios potenciais

Participating in this study might offer a potential benefit of continuing to receive a treatment that could help manage your PAH, and you'll receive careful medical monitoring. However, as with any medicine, there's a risk of side effects, which would be explained fully by the study team. Some participants might receive a placebo, meaning they won't be getting the active drug. You are free to leave the study at any time for any reason without it affecting your medical care.

Locations (45)

  • USA005
    Código postal verificado
    Jacksonville, Estados Unidos
  • USA011
    Código postal verificado
    Tampa, Estados Unidos
  • USA006
    Código postal verificado
    Chicago, Estados Unidos
  • USA001
    Código postal verificado
    Chicago, Estados Unidos
  • USA102
    Código postal verificado
    Nova Iorque, Estados Unidos
  • USA016
    Código postal verificado
    Dallas, Estados Unidos
  • ARG009
    Código postal verificado
    Quilmes, Argentina
  • ARG006
    Código postal verificado
    Rosario, Argentina
  • ARG007
    Código postal verificado
    San Miguel de Tucumán, Argentina
  • ARG004
    Código postal verificado
    Córdoba, Argentina
  • ARG001
    Código postal verificado
    Córdoba, Argentina
  • AUT002
    Código postal verificado
    Linz, Austria

Perguntas frequentes

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a rare but serious condition where the blood vessels in your lungs become narrow. This makes it harder for your heart to pump blood, leading to symptoms like shortness of breath and tiredness.

What is Treprostinil Palmitil (TPIP)?

TPIP is an inhaled medicine, meaning you breathe it in. It's being studied as a possible treatment for PAH to help open up the blood vessels in the lungs.

Why is this study only for people who were in earlier TPIP studies?

This is an 'extension' study. Its main purpose is to see how safe TPIP is over a longer period in people who have already been exposed to it, rather than starting treatment for the first time.

Saberei se estou recebendo o medicamento real ou um placebo?

Often in these types of studies, participants don't know whether they are receiving the active medicine or a placebo to ensure fair results. The study team will explain how this works.

E se minha saúde mudar durante o estudo?

Your health will be monitored regularly by the study team, and you should always report any new or worsening symptoms. They will provide guidance and care based on your condition.

Como saber mais

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Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

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