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Be Part of Research - Trial Details - Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Completed

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Hemoglobinuria
Hemoglobinuria, Paroxysmal
Hemolysis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2020 Jun 2022

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oral tablet

Intervention Arm Group : Danicopan + C5 Inhibitor;

Intervention Type : DRUG
Intervention Description : Oral tablet

Intervention Arm Group : Placebo + C5 Inhibitor;

Intervention Type : DRUG
Intervention Description : Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.

Intervention Arm Group : Danicopan + C5 Inhibitor;Placebo + C5 Inhibitor;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Airdrie
    ML6 0JS
  • Research Site
    London
    SE5 9NU
  • Research Site
    Leeds
    BD7 1DP


The study is sponsored by Alexion Pharmaceuticals, Inc.




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Read full details for Trial ID: NCT04469465
Last updated 01 February 2024

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