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New hope for thalassemia patients: drug may cut blood transfusions

NCT ID NCT07215975

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study is testing a drug called luspatercept in adults with a severe blood disorder called beta-thalassemia who need regular blood transfusions. The goal is to see if the drug can reduce how many transfusions they need and improve their hemoglobin levels. Researchers will follow 200 participants in the Middle East to track real-world results.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2031

An estimate. End dates often move.

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.

Who is studied

The study population will include adult patients with transfusion-dependent β-thalassemia (TDT) in the Middle East region who have initiated luspatercept treatment

Ages

18 years 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: * Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment * Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT). * Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing. * Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study. * Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study Exclusion Criteria: * Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC. * Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation. * Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period. * Participants who have not provided signed informed consent for participating in the study and for collecting and analysing medical data pertinent to the objectives of this study.

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Conditions

The condition(s) this trial relates to.

beta thalassemia beta-thalassemia major thalassemia

As listed by the trial registrant

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

Thalassemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • King Saud Medical Complex

    RECRUITING

    Riyadh, 12746, Saudi Arabia

  • Local Institution - 102

    NOT_YET_RECRUITING

    Jizan, 82943, Saudi Arabia

  • Local Institution - 105

    NOT_YET_RECRUITING

    Mecca, 24241, Saudi Arabia

  • Local Institution - 106

    NOT_YET_RECRUITING

    Dammam, 32263, Saudi Arabia

  • Local Institution - 109

    NOT_YET_RECRUITING

    Al Hofuf and Al Mubarraz, 36422, Saudi Arabia

  • Local Institution - 201

    NOT_YET_RECRUITING

    Andalusia, 70050, Kuwait

  • Local Institution - 202

    NOT_YET_RECRUITING

    Al Jahra, 00020, Kuwait

  • Local Institution - 203

    NOT_YET_RECRUITING

    Kuwait City, 20001, Kuwait

  • Local Institution - 501

    NOT_YET_RECRUITING

    Abu Dhabi, 0, United Arab Emirates

  • Local Institution - 503

    NOT_YET_RECRUITING

    Al Ain City, Abu Dhabi Emirate, 15258, United Arab Emirates

  • Prince Mohammed Bin Fahad Hospital

    RECRUITING

    Al Qaţīf, 32654, Saudi Arabia

  • Sheikh Shakhbout Medical City (SSMC)

    RECRUITING

    Abu Dhabi, Abu Dhabi Emirate, 11001, United Arab Emirates

  • Sultan Qaboos University Hospital

    RECRUITING

    Seeb, Muḩāfaz̧at Masqaţ, 123, Oman

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