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Ativo, mas não recrutandoFASE3INTERVENCIONISTA

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

This research study is investigating a new combination of two medications, pozelimab and cemdisiran, for adults living with a rare blood disorder called Paroxysmal Nocturnal Hemoglobinuria (PNH). The main goals are to find out how safe this new combination is and how well it works. We're also comparing its effects to two established PNH treatments, ravulizumab and eculizumab. Participants are adults who haven't recently received or have never had treatment with complement inhibitor medicines for their PNH. The study will help us understand side effects, how the body handles these new drugs, and whether the body might make antibodies against them, which could affect their usefulness.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE3
Patrocinador
Regeneron Pharmaceuticals
Meta de inscrição
202
Iniciar
01 Aug 2022
Conclusão estimada
26 Oct 2026

Sobre o que é este estudo?

This study is exploring potential new treatments for a rare blood condition called Paroxysmal Nocturnal Hemoglobinuria, often shortened to PNH. PNH causes red blood cells to break down too early, leading to symptoms like tiredness, anaemia, and sometimes blood clots. Currently, there are treatments available, but researchers are always looking for new and potentially better options.

This particular study is focusing on a new combination of two experimental drugs called pozelimab and cemdisiran. The main purpose is to see how safe this combination is for people with PNH and how effectively it helps manage their condition. To understand its benefits, the study will compare this new combination with two existing and commonly used PNH treatments: ravulizumab and eculizumab.

By comparing these treatments, the study aims to answer important questions. We want to know if the new pozelimab and cemdisiran combination is as good as, or even better than, the current treatments. Researchers will also be carefully monitoring for any side effects and learning how the body processes these new medications. This helps us understand if the new treatment could be a valuable option for future PNH patients.

Pontos principais

  • This study investigates a new combination treatment for PNH.
  • It compares new drugs (pozelimab + cemdisiran) with existing PNH treatments.
  • Safety and effectiveness for adults with PNH are key goals.
  • A participação envolve visitas regulares à clínica e exames de saúde.
  • Meningitis vaccinations are a crucial eligibility requirement.

Quem pode ser elegível?

To join this study, you must be an adult (18 years or older) with PNH that has been officially diagnosed through special blood tests. Your PNH needs to be 'active,' meaning you're currently experiencing symptoms or signs of the condition, and certain blood levels (LDH level) must be above a specific point.

You also need to be able to attend all the study appointments, whether they are in person or online. It's very important that you are willing and able to get specific meningitis vaccinations, if you haven't had them already, as required by the study plan.

There are also reasons why you might not be able to join. For instance, if you've recently had certain PNH treatments (like eculizumab within the last 3 months, or ravulizumab within the last 6 months), or if you've had an organ or bone marrow transplant. You also can't participate if you weigh less than 40 kilograms, plan to use other PNH treatments not part of the study, or have certain infections.

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. Are you an adult (18 years or older)?
  2. Have you been diagnosed with PNH?
  3. Are you experiencing active PNH symptoms or signs?
  4. Are you willing and able to get meningitis vaccinations if needed?
  5. Have you not recently received specific PNH complement inhibitor treatments (e.g., eculizumab in last 3 months, ravulizumab in last 6 months)?
  6. Have you NOT had an organ or bone marrow transplant?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you will likely receive either the new drug combination (pozelimab + cemdisiran) or one of the existing PNH treatments (ravulizumab or eculizumab). These will be given over a period of time as determined by the study. You will have regular visits, which might be in person at a clinic or sometimes done remotely. During these visits, the study team will carry out health checks, take blood samples to see how the treatment is working, and ask about any side effects you might be experiencing. They will also look at how much medication is in your blood and if your body is making antibodies against the study drugs. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Riscos e benefícios potenciais

Taking part in this study could offer some potential benefits, such as receiving a PNH treatment under close medical supervision, potentially including a new investigational drug that might improve your condition. However, there are also potential risks, including side effects from the study drugs, which could be mild or severe. Like any medical treatment, there's no guarantee the new drugs will work for you. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Localizações (68)

  • The Oncology Institute of Hope & Innovation
    Código postal verificado
    Whittier, Estados Unidos
  • Centro de Estudos e Pesquisas em Hematologia e Oncologia
    Código postal verificado
    Santo André, Brazil
  • A Beneficencia Portuguesa de Sao Paulo, BP Mirante
    Código postal verificado
    São Paulo, Brazil
  • Casa de Saude Santa Marcelina
    Código postal verificado
    São Paulo, Brazil
  • Toronto General Hospital
    Código postal verificado
    Toronto, Canadá
  • Peking Union Medical College Hospital
    Código postal verificado
    Pequim, China
  • Hospital Pablo Tobon Uribe
    Código postal verificado
    Medellín, Colombia
  • George Papanikolaou Hospital
    Código postal verificado
    Thessaloniki, Greece
  • Semmelweis University
    Código postal verificado
    Budapest, Hungary
  • Malabar Cancer Center, Kerala
    Código postal verificado
    Kannur, India
  • Amrita Institute of Medical Sciences (AIMS) and Research Centre Aims
    Código postal verificado
    Kochi, India
  • K J Somaiya Super Specialty Hospital & Research Centre
    Código postal verificado
    Mumbai, India

Perguntas frequentes

What is PNH?

PNH stands for Paroxysmal Nocturnal Hemoglobinuria. It's a rare blood condition where red blood cells break down too quickly, which can cause symptoms like tiredness.

Are the new drugs safe?

The study aims to find out how safe the new drug combination, pozelimab and cemdisiran, is. All study medications are carefully monitored for any side effects.

Will I get the new treatment or an existing one?

During the study, you will be given either the new combination treatment or one of two existing, approved treatments for PNH (ravulizumab or eculizumab).

Quanto tempo estarei no estudo?

The exact length of your participation will be fully explained by the study team. It will involve regular visits and check-ups over a period of time.

Posso parar de participar a qualquer momento?

Yes, you have the right to leave the study at any point, for any reason, without it affecting your medical care.

Como saber mais

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

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.