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NCT05675436 · ClinicalTrials.gov registry record

Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease

A clinical trial of Sickle Cell Anemia and Sickle Beta Zero Thalassemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Active
Registry status
6
Enrollment target
1
Study location

NCT05675436: Active study of Sickle Cell Anemia and Sickle Beta Zero Thalassemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

NCT05675436 is a study of Sickle Cell Anemia and Sickle Beta Zero Thalassemia that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 6 participants, below the 100-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05675436, a study of Sickle Cell Anemia and Sickle Beta Zero Thalassemia, is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

ACTIVE NOT RECRUITING
Registry status
6 participants
Enrollment target
1
Study location

Study Summary

Background: Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen; this in turn can injure organs including the heart, lungs, and kidneys. SCD can lead to serious illness and death. Treatments such as bone marrow transplants and gene therapies can cure SCD, but they are not widely available. Current drug treatments for SCD are not always effective. This natural history study will examine how a study drug (mitapivat) affects red blood cells in people with SCD. Objective: To learn how mitapivat affects red blood cells in people with SCD. Eligibility: People with SCD who are enrolled in the parent study, NIH protocol IRB001565-H. Design: Procedures for this study will be done during visits already scheduled for the parent study. Participants will have additional blood drawn during study visits. The additional amount will be about 3.5 teaspoons. Participants will undergo a test called near infrared spectroscopy (NIRS) up to 9 times. Probes will be placed on their skin. A blood pressure cuff will be placed on their arm. The cuff will be filled with air for up to 5 minutes and then released. Participants may be asked to breathe at a certain rate or to hold their breath during these measurements. NIRS measures oxygen levels, blood flow, and the makeup of skin and muscle. Researchers will draw additional information for this study from participants medical records.

Primary Outcome

This change will be compared between the placebo and mitapivat arms.

Conditions Studied

Sickle Cell Anemia Sickle Beta Zero Thalassemia Sickle Cell Thalassemia Sickle Cell Pain Hbss Hbsc Sickle Beta Thalassemia Sickle Cell Syndrome Variant

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2024-05-09
Est. Completion 2027-10-27
National Heart, Lung, and Blood Institute (NHLBI)

501 total trials

What the registry record for NCT05675436 still lists

NCT05675436 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 100-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (94% lower).

The record links to 8 conditions, with Sickle Cell Anemia appearing as the primary indexed condition, and to 0 interventions.

NCT05675436 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT05675436 about?

NCT05675436 is a clinical study titled "Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease". Background: Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen; this in turn can injure organs including the heart, lungs, and kidneys. SCD can lead to serious illness and death. Treatments such as bone marrow transplants and...

What is the current status of trial NCT05675436?

This trial is currently active not recruiting. The enrollment target is 6 participants. The study started on 2024-05-09. Estimated completion is 2027-10-27.

What conditions does trial NCT05675436 study?

This clinical trial studies the following conditions: Sickle Cell Anemia, Sickle Beta Zero Thalassemia, Sickle Cell Thalassemia, Sickle Cell Pain, Hbss.

Who is sponsoring clinical trial NCT05675436?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05675436 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sickle Cell Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05675436's enrollment target sits among peer trials

6 21st of 22 higher than 2 of 22 other Sickle Cell Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sickle Cell Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05675436, the US trial registry maintained by the National Library of Medicine. NCT05675436 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.