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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 172 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 5 versions Re-verified since Feb 14, 2026, no change to tracked fieldsv168-v172
  2. Study description shortened, about 1 wordv167
  3. 8 versions Re-verified since May 9, 2025, no change to tracked fieldsv159-v166
  4. Eligibility criteria revisedv158
  5. Re-verified, no change to tracked fieldsv157
Show 34 earlier versionsHide 34 earlier versions
  1. Eligibility criteria expanded, about 20 words
    • Study description expanded, about 33 words
    v156
  2. 20 versions Re-verified since Oct 5, 2023, no change to tracked fieldsv136-v155
  3. Study description expanded, about 20 wordsv135
  4. 5 versions Re-verified since Apr 29, 2023, no change to tracked fieldsv130-v134
  5. Primary completion date: Apr 15, 2023 to Feb 28, 2028
    • Study completion date: Oct 19, 2023 to Feb 28, 2028
    v129
  6. 4 versions Re-verified since Dec 6, 2022, no change to tracked fieldsv125-v128
  7. Eligibility criteria shortened, about 17 wordsv124
  8. Re-verified, no change to tracked fieldsv123
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Sickle cell disease (SCD) is a disorder that causes episodes of acute pain and progressive organ damage. Ways to manage SCD have evolved slowly. Treatments do not always work. Researchers want to see if a drug called mitapivat can help people with SCD. Objective: To test the long-term tolerability and safety of mitapivat (or AG-348) in people with SCD. Eligibility: Adults age 18-70 with SCD who took part in and benefited from NIH study #19H0097. Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. They will have an electrocardiogram to test heart function. Participants will repeat some of the screening tests during the study. Participants will complete 6-minute walk tests to measure mobility and function. They will have transthoracic echocardiograms to measure heart and lung function. They will have dual-energy X-ray absorptiometry scans to measure bone health. They will complete online questionnaires that measure their overall health and well-being. Participants will take the study drug in the form of a tablet twice a day. Participants will keep a study diary. They will record any symptoms they may have. Participation will last for about 54 weeks. After 48 weeks, participants can either keep taking the study drug for 48 more weeks or be tapered off of the study drug to complete the study. Those who are on the study for 1 year will have 10 study visits. Those who are on the study for 2 years will have 14 study visits.
Trial Details
NCT Number NCT04610866
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Sickle Cell Disease, Hemolytic Anemia
Related terms Anemia, Hemolytic, Anemia, Sickle Cell
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov