Patient Research
Sign in
All studies
Enrolling by invitationOBSERVATIONAL

Long-Term Follow-up of Subjects Who Were Treated With ST-920

This study is a long-term follow-up for people who previously received an investigational medicine called ST-920 for Fabry disease, including a type affecting the heart. Participants had already completed at least a year of follow-up in the initial trial. This new study will continue to monitor their health for up to five years after they first received ST-920. It's designed to see how the treatment affects their health over a longer period. This is an observational study, meaning participants won't receive new ST-920 treatment but will have their health regularly checked to understand the long-term impact of the previous trial medication.

At a glance

Status
Enrolling by invitation
Sponsor
Sangamo Therapeutics
Enrolment target
48
Start
16 Aug 2021
Estimated completion
01 Mar 2039
Fabry DiseaseFabry Disease, Cardiac Variant

What is this study about?

This study is called a long-term follow-up study. Its main purpose is to continue observing the health of people who have previously been treated with an investigational medicine called ST-920 for Fabry disease. Fabry disease is a rare genetic condition that can affect many parts of the body, including the heart. This study specifically includes individuals with Fabry disease, and a variation that primarily affects the heart.

Participants in this study already received ST-920 in an earlier clinical trial (called ST-920-201) and have already been followed for at least one year after their treatment. This new study is designed to gather more information over a longer period, up to a total of five years from when they first received ST-920. Researchers want to understand if the effects of the treatment last, and if there are any long-term changes or effects on their health.

This is not a study where you would receive new treatment with ST-920. Instead, it's about carefully watching and recording health details of those who have already had the treatment. This kind of follow-up is very important in medicine to get a complete picture of how new treatments work over time, which helps improve care for future patients with Fabry disease.

Key takeaways

  • This study tracks long-term health after ST-920 treatment for Fabry disease.
  • It's for people who participated in a previous ST-920 trial.
  • No new medication is given; it's an observational study.
  • Participants will be followed for up to five years after their initial treatment.
  • Data collected will help understand long-term treatment effects.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this long-term follow-up study, you must have previously taken part in the ST-920-201 clinical trial and received the ST-920 treatment in that study. Additionally, you need to have completed at least one full year of follow-up after your last treatment in that previous trial.

Finally, you must be willing and able to give your informed consent to participate in this specific long-term follow-up study. You’ll be asked to formally agree to join after understanding all the details of what it involves.

There are no reasons that would prevent someone from joining this study if they meet the above requirements.

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. Did you take part in the ST-920-201 study?
  2. Did you receive ST-920 treatment in that study?
  3. Have you completed at least a year of follow-up since your last ST-920 treatment?
  4. Are you 18 years old or older?
  5. Are you willing to discuss and provide your informed consent to join this study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be receiving any new medication. Instead, the study involves regular check-ups to monitor your health over time. These check-ups will include various assessments, which might involve physical examinations, blood tests, and other procedures that are part of standard care for Fabry disease. The specific schedule and types of visits will be explained to you in detail.

Your participation will help researchers understand the long-term effects of the ST-920 treatment you received previously. The total duration of your participation in this follow-up study could be up to five years from the date you first received ST-920 in the earlier trial. This means the time you spend in this study will vary depending on how much time has passed since your last treatment in the original trial.

Potential risks and benefits

The main benefit of participating is contributing to a better understanding of how ST-920 affects people with Fabry disease over many years. This could help doctors and researchers improve treatments for others in the future. As you are not receiving new medication, the risks are generally associated with the procedures involved in monitoring your health, such as minor discomfort from blood draws. All procedures will be explained to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California, Irvine
    Verified postcode
    Irvine, United States
  • University of South Florida
    Verified postcode
    Tampa, United States
  • Emory University School of Medicine
    Verified postcode
    Atlanta, United States
  • University of Iowa Hospital and Clinics
    Verified postcode
    Iowa City, United States
  • University of Minnesota Medical Center
    Verified postcode
    Minneapolis, United States
  • Mt. Sinai Hospital
    Verified postcode
    New York, United States
  • Cincinnati Children's Hospital Medical Center
    Verified postcode
    Cincinnati, United States
  • Lysosomal & Rare Disorders Research & Treatment Center (LDRTC)
    Verified postcode
    Fairfax, United States
  • The Royal Melbourne Hospital
    Verified postcode
    Parkville, Australia
  • M.A.G.I.C. Clinic Ltd.
    Verified postcode
    Calgary, Canada
  • University Hospital of Würzburg
    Verified postcode
    Würzburg, Germany
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom

Common questions

What is the main goal of this study?

The goal is to track the health of people who previously received ST-920 for Fabry disease, to understand the long-term effects of the treatment over several years.

Will I receive more ST-920 medicine in this study?

No, you will not receive new doses of ST-920 in this study. It's purely for observing the long-term outcomes of your previous treatment.

How long will I be in this study?

You could be followed for up to five years in total from when you first received ST-920 in the original trial, depending on how long you've already been followed.

What will I have to do if I join?

You'll have regular health check-ups, which might include physical exams and blood tests, to monitor your health and how the treatment has affected you.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "Long-Term Follow-up of Subjects Who Were Treated With ST-920…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.