Search / Trial NCT06225882

Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France.

Launched by HOSPICES CIVILS DE LYON · Jan 17, 2024

Trial Information

Current as of December 30, 2024

Recruiting

Keywords

Lumarisan Primary Hyperoxaluria Type 1 (Ph1) Retrospective And Prospective Data.

ClinConnect Summary

This clinical trial is looking at how well a treatment called Lumasiran works for people with a rare genetic condition known as primary hyperoxaluria type 1 (PH1). PH1 happens when a specific gene in the liver doesn’t work properly, leading to a build-up of substances that can cause kidney stones and other serious kidney problems. While previous studies showed that Lumasiran can be effective and safe, this trial aims to gather more long-term information about how well it works and how it affects patients over time. Researchers will be following patients in France who have been treated with Lumasiran for up to five years, keeping track of their health and the levels of certain substances in their bodies.

To be part of this study, patients need to have been diagnosed with primary hyperoxaluria type 1 and have received Lumasiran treatment. There are a few basic requirements: participants can be anyone from infants to adults, and they must not oppose their involvement in the study. During the trial, patients can expect regular check-ups that include clinical assessments, lab tests, and imaging studies to monitor their condition. This study is important because it will help gather valuable information to better understand the long-term benefits and safety of Lumasiran for those living with PH1.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient with primary hyperoxaluria type 1 who has been treated with Lumasiran, since the beginning of the ATU (temporary authorization for use) and in post-marketing.
  • Exclusion Criteria:
  • Opposition of the patient or his legal representatives for minors.
  • Not covered by social security.

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Besançon, , France

Lyon, , France

Bron, , France

Paris, Ile De France, France

Paris, , France

Marseille, , France

Paris, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0