A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT07656415
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this study is to determine the effect of mitapivat versus placebo on the need for transfusions in subjects with SCD.

Key Dates

First listed
Jun 18, 2026
Start date
Jul 21, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mitapivat
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Percentage of Subjects who are Transfusion Free From Week 4 Through Week 52 [ Time Frame: Week 4 through Week 52 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana Hemophilia & Thrombosis CenterIndianapolisIndiana46260-
The Cancer and Hematology Centers (CHC)Grand RapidsMichigan49503-
Southern Specialty ClinicFlowoodMississippi39232-

Find similar trials in Indianapolis, IN

Nationwide
Sickle cell disease trials
By condition
Sickle cell disease
By research site
Indiana Hemophilia & Thrombosis Center· Indianapolis, INThe Cancer and Hematology Centers (CHC)· Grand Rapids, MISouthern Specialty Clinic· Flowood, MS

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