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.

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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:

90

Study ID:

NCT05389449

Recruitment Status:

Active, not recruiting

Sponsor:

Alexion Pharmaceuticals, Inc.

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There are 40 Locations for this study

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Clinical Trial Site
Los Angeles California, 90033, United States
Clinical Trial Site
Chicago Illinois, 60612, United States
Clinical Trial Site
Baltimore Maryland, 21287, United States
Clinical Trial Site
Kansas City Missouri, 64111, United States
Clinical Trial Site
New York New York, 10065, United States
Clinical Trial Site
Cleveland Ohio, 44195, United States
Clinical Trial Site
Dallas Texas, 75390, United States
Clinical Trial Site
Porto Alegre RS, 90110, Brazil
Clinical Trial Site
Toronto Ontario, M5G2C, Canada
Clinical Trial Site
Lille , 59037, France
Clinical Trial Site
Paris , 75475, France
Clinical Trial Site
Pessac , 33604, France
Clinical Trial Site
Pierre Benite , 69495, France
Clinical Trial Site
Avellino AV, 83100, Italy
Clinical Trial Site
Milano Lombardia, 20122, Italy
Clinical Trial Site
Rome RM, 00161, Italy
Clinical Trial Site
Bassano del Grappa , 36061, Italy
Clinical Trial Site
Firenze , 50134, Italy
Clinical Trial Site
Reggio Calabria , 89133, Italy
Clinical Trial Site
Tsukuba-shi Ibaraki, 305-8, Japan
Clinical Trial Site
Kyoto-shi Kyoto, 605-0, Japan
Clinical Trial Site
Osaka-shi Osaka, 530-8, Japan
Clinical Trial Site
Bunkyo-ku Tokyo, 113-8, Japan
Clinical Trial Site
Shibuya-ku Tokyo, 150-8, Japan
Clinical Trial Site
Fukuoka-shi , 812-8, Japan
Clinical Trial Site
Seoul , 03722, Korea, Republic of
Clinical Trial Site
Seoul , 06591, Korea, Republic of
Clinical Trial Site
Suwon-si , 16247, Korea, Republic of
Clinical Trial Site
Kota Kinabalu Sabah, 88586, Malaysia
Clinical Trial Site
Kuching Sarawak, 93586, Malaysia
Clinical Trial Site
Miri Sarawak, 98000, Malaysia
Clinical Trial Site
Gdansk Pomorskie, 80-21, Poland
Clinical Trial Site
Sevilla Andalucia, 41013, Spain
Clinical Trial Site
Barcelona Cataluña, 08036, Spain
Clinical Trial Site
Barcelona Cataluña, 08916, Spain
Clinical Trial Site
Madrid , 28222, Spain
Clinical Trial Site
Bangkok , 10330, Thailand
Clinical Trial Site
Leeds West Yorkshire, LS9 7, United Kingdom
Clinical Trial Site
Airdrie , ML6 0, United Kingdom
Clinical Trial 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:

90

Study ID:

NCT05389449

Recruitment Status:

Active, not recruiting

Sponsor:


Alexion Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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