Authorised Therapeutic use (Phase IV) Paroxysmal nocturnal hemoglobinuria (PNH)

Ravulizumab dose optimization

EU CTIS ID: 2024-519207-10-00

What this study is testing

The main objective is to describe the effectiveness of individualized dosing of ravulizumab compared to standard dosing of ravulizumab in adult PNH patients.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The patient is eligible for treatment with ravulizumab in line with relevant Dutch guidelines or is already being treated with ravulizumab according to the label and Dutch guidelines.
  • Willing to provide written informed consent
  • 16 years or older

You likely can't join if

  • Patients with thrombosis during treatment with complement inhibitors in the medical history
  • Patients with other concomitant hematological diseases, with the exception for aplastic anemia/PNH
  • Unstable medical conditions (e.g. myocardial infarction, bleeding)
  • Pregnant or lactating patients
  • An LDH >1.5x ULN during the 8 weeks prior to screening for inclusion
  • Use of high dose corticosteroids(defined as >30mg prednisolone equivalent daily during the 8 weeks prior to the screening for inclusion)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.