Myelodysplastic Syndrome Clinical Trial

A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

Summary

This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.

View Full Description

Full Description

The total duration of the study will be up to 3 years. Eligible participants must complete all study assessments on the parent protocol before starting this study. All participants entering this study will receive danicopan as an add-on to a background C5i therapy. The only allowed C5i therapies are eculizumab and ravulizumab.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

All participants who completed their participation in an Alexion sponsored clinical study with danicopan as an add on to a C5i treatment.
Patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Documentation of vaccination for Neisseria meningitidis: All participants must be revaccinated as per national vaccination guidelines or local practice for vaccination use with complement inhibitors.

Key Exclusion Criteria:

Any medical condition (for example, cardiac, pulmonary, renal, oncologic, or psychiatric) that, in the opinion of the Investigator, might interfere with participation in the study, pose any added risk to the participant, or confound the assessment of the participant.
Patient has been permanently discontinued from danicopan in the parent study for any reason other than enrollment into this LTE study.
Female participants who are pregnant, breastfeeding, or intending to conceive during the course of the study.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

80

Study ID:

NCT05389449

Recruitment Status:

Active, not recruiting

Sponsor:

Alexion Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 44 Locations for this study

See Locations Near You

Research Site
Los Angeles California, 90089, United States
Research Site
Chicago Illinois, 60612, United States
Research Site
Baltimore Maryland, 21231, United States
Research Site
Kansas City Missouri, 64111, United States
Research Site
Long Island City New York, 11101, United States
Research Site
Cleveland Ohio, 44195, United States
Research Site
Dallas Texas, 75390, United States
Research Site
Porto Alegre , 90110, Brazil
Research Site
Rio de Janeiro , 20211, Brazil
Research Site
Toronto Ontario, M5G 2, Canada
Research Site
Brno , 625 0, Czechia
Research Site
Lille , 59037, France
Research Site
Paris , 75010, France
Research Site
Pessac , 33604, France
Research Site
Pierre Benite Cedex , 69495, France
Research Site
Athens , 11527, Greece
Research Site
Thessaloniki , 57010, Greece
Research Site
Haifa , 31048, Israel
Research Site
Jerusalem , 91120, Israel
Research Site
Avellino , 83100, Italy
Research Site
Bassano del Grappa , 36061, Italy
Research Site
Firenze , 50134, Italy
Research Site
Milano , 20122, Italy
Research Site
Reggio Calabria , 89131, Italy
Research Site
Roma , 161, Italy
Research Site
Bunkyo-Ku , 113 8, Japan
Research Site
Kyoto-shi , 605-0, Japan
Research Site
Osaka-shi , 530-8, Japan
Research Site
Shibuya-ku , 150-8, Japan
Research Site
Tsukuba-shi , 305-8, Japan
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 06591, Korea, Republic of
Research Site
Suwon , 16247, Korea, Republic of
Research Site
Kota Kinabalu , 88586, Malaysia
Research Site
Kuching , 93200, Malaysia
Research Site
Miri , 98000, Malaysia
Research Site
Gdańsk , 80-95, Poland
Research Site
Badalona , 8916, Spain
Research Site
Barcelona , 08036, Spain
Research Site
Majadahonda , 28222, Spain
Research Site
Sevilla , , Spain
Research Site
Bangkok , 10330, Thailand
Research Site
Airdrie , ML6 0, United Kingdom
Research Site
Leeds , LS9 7, United Kingdom
Research Site
London , SE5 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

80

Study ID:

NCT05389449

Recruitment Status:

Active, not recruiting

Sponsor:


Alexion Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.