Mitapivat for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this study is to determine the effect of mitapivat versus placebo on the need for transfusions in subjects with SCD.
Are You a Good Fit for This Trial?
This trial is for people aged 12 and older with sickle cell disease who have needed at least one blood transfusion in the past year, meet certain lab criteria, and are willing to follow study rules. If taking hydroxyurea, their dose must be stable. Women able to get pregnant must use effective birth control.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Mitapivat
Trial Overview
The study compares mitapivat (an oral medication) to a placebo to see if it reduces the need for blood transfusions in people with sickle cell disease. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Subjects will receive oral mitapivat 100 milligrams (mg), twice daily (BID), for up to 52 Weeks during the double blind (DB) period. Subjects who will complete the DB period may continue receiving mitapivat for up to 52 weeks in the open-label extension (OLE) period.
Subjects will receive oral mitapivat matching placebo, BID, for up to 52 weeks during the DB period. Subjects who will complete the DB period may continue to receive mitapivat for up to 52 weeks in the OLE period.
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Who Is Running the Clinical Trial?
Agios Pharmaceuticals, Inc.
Lead Sponsor
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