All studies
Active not recruitingOBSERVATIONAL

Pyruvate Kinase Deficiency Global Longitudinal Registry

This study is like a large, ongoing look into a rare blood condition called Pyruvate Kinase Deficiency (PKD). It's not a clinical trial where you try new medicines; instead, researchers will simply gather information from people with PKD worldwide. This will help them understand how the condition naturally develops over many years, how it's treated, and how it affects daily life. Doctors will share patient information, and some details will come directly from patients or their parents. The goal is to collect a lot of useful data to eventually improve the care and understanding of PKD for everyone affected.

At a glance

Status
Active not recruiting
Sponsor
Agios Pharmaceuticals, Inc.
Enrolment target
500
Start
23 Apr 2018
Estimated completion
31 May 2027

What is this study about?

This study is looking into a rare inherited blood condition called Pyruvate Kinase Deficiency, or PKD. People with PKD have a problem with their red blood cells, which can sometimes lead to anaemia and other health issues.

Instead of testing new treatments, this study is a 'registry'. Think of it as a large, organised way to collect information from many different people with PKD around the world. The aim is to understand how PKD affects people over a long time, the types of treatments they receive, and how the condition impacts their lives. By gathering this detailed information from lots of patients, doctors can get a much clearer picture of PKD, which will hopefully lead to better ways to manage and treat it in the future.

Researchers will collect information that doctors already record, like blood test results, details about hospital visits, and different treatments given. They will also collect general details about patients, such as their age and when they were diagnosed. This information will be regularly updated over several years to see how PKD changes and how different treatments work over time.

Key takeaways

  • This is a study to understand a rare blood condition called Pyruvate Kinase Deficiency (PKD).
  • It collects information from patients worldwide, not a new treatment trial.
  • Data includes existing medical records, not new tests.
  • Participation is for at least 2 years, potentially up to 9 years.
  • Information gathered aims to improve future care for PKD patients.
  • You can stop participating at any time without affecting your care.

Who may be eligible?

Anyone of any age who has been officially diagnosed with Pyruvate Kinase Deficiency (PKD) can potentially join this study. This diagnosis usually needs to be confirmed by a genetic test, which looks at your genes.

Even if your genetic test results are unusual or new, you might still be able to join if your doctor believes your genetic changes are definitely causing your PKD.

Importantly, you or your parent/guardian (if you are a child) must be willing and able to give your clear permission to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have a confirmed diagnosis of Pyruvate Kinase Deficiency (PKD)?
  2. Was your PKD diagnosis confirmed by a genetic test?
  3. Are you (or your parent/guardian) willing to give permission for your medical information to be shared for this study?
  4. Are you of any age?
Answer every question to see your result.

What does participation involve?

If you decide to take part, doctors will regularly share information they already collect about your condition with the study. This includes details from your medical records, like blood test results (such as haemoglobin levels, which tell us about your red blood cells), and any treatments you're receiving (like blood transfusions or medicines). You won't have any extra appointments or tests specifically for this study. Your doctors will just provide updates on your health status once a year based on your usual check-ups. The study plans to collect information for at least two years and potentially up to nine years, but you can choose to leave the study at any time.

Potential risks and benefits

There are no direct medical benefits for you from taking part in this study, as it doesn't involve new treatments or extra tests. However, the information gathered could help doctors better understand PKD and improve care for others in the future. The main risk is a very small chance that your personal information could be seen by someone it shouldn't be, even though researchers will take strong steps to protect your privacy. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (52)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Phoenix Childrens Hospital
    Verified postcode
    Phoenix, United States
  • Arkansas Children's Hospital
    Verified postcode
    Little Rock, United States
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States
  • Children's Hospital of Orange County
    Verified postcode
    Orange, United States
  • Stanford University Medical Center
    Verified postcode
    Palo Alto, United States
  • Children's Healthcare of Atlanta
    Verified postcode
    Atlanta, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • Boston Children's Hospital
    Verified postcode
    Boston, United States
  • UMass Memorial Medical Center
    Verified postcode
    Worcester, United States
  • Children's Hospital of Michigan
    Verified postcode
    Detroit, United States
  • Duke University Medical Center
    Verified postcode
    Durham, United States
  • Children's Hospital of Philadelphia
    Verified postcode
    Philadelphia, United States

Common questions

What is Pyruvate Kinase Deficiency (PKD)?

PKD is a rare inherited blood condition where red blood cells don't work properly, which can lead to anaemia and other health issues.

Is this a study where I try a new medicine?

No, this is not a study where you try new medicines. It's an information-gathering study to learn more about PKD.

Will I have extra doctor's appointments?

No, you won't need extra appointments. Information will be collected from your regular doctor's visits.

How long will the study last?

The study aims to collect information for at least 2 years, and possibly up to 9 years in total.

Can I stop participating if I change my mind?

Yes, you can choose to stop participating at any time without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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