Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Sickle cell drug safety trial ends early

NCT ID NCT05632354

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug osivelotor in people with sickle cell disease who had already taken it in an earlier trial. The goal was to track side effects and blood changes over time. However, the study was terminated early, so the full safety picture is not yet known.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Osivelotor (a drug to help red blood cells carry oxygen better)
What this could lead to
If successful, this could provide a long-term treatment option to reduce painful crises in sickle cell disease.
What could go wrong
The trial was terminated early, so long-term safety and effectiveness data are limited. It is still an experimental drug with unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

47 people

The number who actually took part.

Started

Jan 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged 6 months or older with SCD who participated and received study drug or placebo in a previous osivelotor clinical study and completed the end of treatment visit. Note: Participants who discontinued study drug in the originating study due to an TEAE, but who remained on study, may be eligible for treatment in this study provided the TEAE does not pose a risk for treatment with osivelotor. 2. Females of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Females who become of childbearing potential during the study must be willing to have negative urine pregnancy tests to remain in the study. 3. If sexually active, females of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 120 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 84 days after the last dose of study drug. Male participants are eligible to participate if they agree to the following requirements during the study intervention period and for 84 days after the last dose of study intervention: * Refrain from donating sperm PLUS either * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle OR * Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person 4. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirements. Exclusion Criteria: * Participant withdrew consent or was noncompliant from the originating osivelotor clinical study * Current or recent use of voxelotor. Recent use is defined as within 10 days prior to Day 1 * Current or recent use of crizanlizumab. Recent use is defined as within 90 days prior to Day 1 * Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent * Has received an investigational drug (including investigational vaccines) within 5 times the elimination half-life (if known) or within 30 days (if the elimination half-life- is unknown) prior to study drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sickle cell disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aminu kano Teaching Hospital

    Kano, 700233, Nigeria

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Lagos University Teaching Hospital

    Lagos, 100254, Nigeria

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi, 39110, United States

  • Our Lady of the Lake Hospital, Inc.

    Baton Rouge, Louisiana, 70808, United States

  • University College Hospital Ibadan

    Ibadan, Oyo/ibadan North, 200212, Nigeria

  • University Medical Center Inpatient Pharmacy

    New Orleans, Louisiana, 70112, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Texas Health Science Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.