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New hope for blood disorder patients: Long-Term safety check for etavopivat

NCT ID NCT06609226

Disease control Sponsor: Novo Nordisk A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 3 times

Summary

This study looks at the long-term safety and effectiveness of etavopivat, an experimental medicine for sickle cell disease and thalassemia. It involves 480 adults, adolescents, and children who have already benefited from etavopivat in a previous study. Participants will continue treatment for up to 264 weeks, or until the drug is approved in their country.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

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

Started

Jan 2025

Expected to finish

Dec 2030

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.

Ages

2 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: * Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study. * Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator. * Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring. * Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status. Exclusion Criteria: * Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study. * Participants on permanent dose reduction (greater than \[\>\] 28 days or more) or ongoing temporary treatment discontinuation. * Use of any of the following within the timeframes prior to the transfer visit as stated: * Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study. * Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study. * Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study. * Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study. * Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.

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Conditions

The condition(s) this trial relates to.

sickle cell disease thalassemia

As listed by the trial registrant

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

Sickle cell disease Thalassemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    72 sites in 16 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • 'Ippokrateio' General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, 54642, Greece

  • Abu El-Reesh El-Mounira Children University Hospital

    RECRUITING

    Cairo, Egypt, 4241317, Egypt

  • Ahero Clinical Trials Unit

    RECRUITING

    Kisumu, 40101, Kenya

  • Alexandria University Hospital

    RECRUITING

    Alexandria, Egypt, 21131, Egypt

  • Alexandria University Hospital

    NOT_YET_RECRUITING

    Alexandria, Egypt, 21131, Egypt

  • All India Institute of Medical Sciences (AIIMS), Raipur

    NOT_YET_RECRUITING

    Raipur, Chhattisgarh, 492099, India

  • All India Institute of Medical Sciences_Delhi

    NOT_YET_RECRUITING

    New Delhi, 110029, India

  • American University of Beirut Medical Centre

    RECRUITING

    Hamra, 11-0236, Lebanon

  • Aminu Kano Teaching Hospital (AKTH)

    NOT_YET_RECRUITING

    Kano, 3452, Nigeria

  • Ap-Hp-Hopital Henri Mondor

    RECRUITING

    Créteil, 94000, France

  • Ap-Hp-Hopital Robert Debre

    RECRUITING

    Paris, 75019, France

  • Ap-Hp-Hopital Robert Debre

    NOT_YET_RECRUITING

    Paris, 75019, France

  • Atrium Health-Wake Forest Bapt

    ACTIVE_NOT_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Atrium Levine Children's/Atrium Health

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Azienda Ospedale Universita Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche

    RECRUITING

    Orbassano, Torino, 10043, Italy

  • Barau Dikko Teaching Hospital, Kaduna

    NOT_YET_RECRUITING

    Kaduna, 800212, Nigeria

  • Baskent Universitesi Adana

    NOT_YET_RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Başkent Üniversitesi Adana-Hematoloji

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Boston Medical Center

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02118, United States

  • CHU Ste-Justine

    COMPLETED

    Montreal, Quebec, H3T 1C5, Canada

  • Cairo University

    RECRUITING

    Cairo, Egypt, 11956, Egypt

  • Center for Blood Disorders Augusta University

    ACTIVE_NOT_RECRUITING

    Augusta, Georgia, 30912, United States

  • Charité - Campus Virchow-Klinikum - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Children's Healthcare Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hosp Of Orange

    COMPLETED

    Orange, California, 92868, United States

  • Children's Hosp-New Orleans

    COMPLETED

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital Los Angeles - Endocrinology

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital Los Angeles - Endocrinology

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's National Medical Center

    COMPLETED

    Washington D.C., District of Columbia, 20010, United States

  • Chronic Care Center

    RECRUITING

    Hazmiyeh, 21211, Lebanon

  • Cincinnati Child's Hsp Med Ctr

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center_New York_0

    RECRUITING

    New York, New York, 10032, United States

  • Columbia University Medical Center_New York_0

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Duke University_Durham

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Carolina Univ-Greenville

    ACTIVE_NOT_RECRUITING

    Greenville, North Carolina, 27834, United States

  • East Carolina University_Greenville

    COMPLETED

    Greenville, North Carolina, 27834, United States

  • Emory University School of Medicine

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30303, United States

  • Evelina London Children's Hospital - Haemophilia

    NOT_YET_RECRUITING

    London, SE1 7EH, United Kingdom

  • Faculty of Medicine Ain Shams Medical Research Institute (MASRI)

    RECRUITING

    Cairo, 1181, Egypt

  • Fondazione IRCCS Policlinico San Matteo

    COMPLETED

    Pavia, 27100, Italy

  • Foundation for Sickle Cell Disease Research

    ACTIVE_NOT_RECRUITING

    Hollywood, Florida, 33023, United States

  • General Hospital Of Larissa Koutlibaneio And Triantafylleio - Thalassemia and SCD Unit

    RECRUITING

    Larissa, Thessaly, 41221, Greece

  • General University Hospital of Patras

    RECRUITING

    Pátrai, 26504, Greece

  • Gertrude's Children's Hospital

    RECRUITING

    Nairobi, Nairobi County, 00509, Kenya

  • Ghana Institute of Clinical Genetics, Korle Bu Teaching Hospital (KBTH)

    RECRUITING

    Accra, 0, Ghana

  • Guy's Hospital

    NOT_YET_RECRUITING

    London, SE1 9RT, United Kingdom

  • Guy's Hospital - Haematology

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hacettepe University Hematology

    NOT_YET_RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hacettepe Üniversitesi Hastanesi- Hematoloji

    NOT_YET_RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hippokration Hospital

    RECRUITING

    Athens, 11527, Greece

  • Hospices Civils de Lyon-Hopital Edouard Herriot

    RECRUITING

    Lyon, 69437, France

  • Hospital Nini

    RECRUITING

    Tripoli, 1434, Lebanon

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario de Cruces

    ACTIVE_NOT_RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Imperial College London

    RECRUITING

    London, W12 0NN, United Kingdom

  • Jacobi Medical Center

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10461, United States

  • K.J Somaiya Hospital and Research Centre

    NOT_YET_RECRUITING

    Mumbai, Maharashtra, 400022, India

  • KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital

    RECRUITING

    Siaya, Siaya County, 40600, Kenya

  • KEMRI Kondele Children Hospital, Kisumu

    RECRUITING

    Kisumu, 40100, Kenya

  • KEMRI-Walter-Reed Kericho

    NOT_YET_RECRUITING

    Kericho, 20200, Kenya

  • King Khalid University Hospital

    RECRUITING

    Riyadh, 12372, Saudi Arabia

  • King's College Hospital - Paediatric Research

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kings College Hospital - Haematology

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kintampo Health Research Centre (KHRC)

    RECRUITING

    Kintampo, Bono East, 27WF+98M, Ghana

  • Kombewa Clinical Research Centre

    RECRUITING

    Kisumu, 1932, Kenya

  • Kombewa Clinical Research Centre

    NOT_YET_RECRUITING

    Kisumu, 1932, Kenya

  • Lagos University Teaching Hospital, Lagos

    NOT_YET_RECRUITING

    Lagos, 102215, Nigeria

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Mary Bridge Children's Health

    ACTIVE_NOT_RECRUITING

    Tacoma, Washington, 98405, United States

  • Medical University Of South Carolina_Charleston

    ACTIVE_NOT_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mersin University Medical Faculty Pediatric Hematology

    NOT_YET_RECRUITING

    Mersin, 33110, Turkey (Türkiye)

  • Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji

    RECRUITING

    Mersin, 33110, Turkey (Türkiye)

  • Methodist University Hospital

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10467, United States

  • NYC Health+Hospitals

    ACTIVE_NOT_RECRUITING

    Brooklyn, New York, 11203, United States

  • Neuro-Behavioral Clinical Research

    ACTIVE_NOT_RECRUITING

    North Canton, Ohio, 44720, United States

  • Nirmal Hospital Pvt. Ltd.

    NOT_YET_RECRUITING

    Gujarat, 395002, India

  • Phoenix Children's Hsptl

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Prince Mohammad Bin Naser Hospital

    NOT_YET_RECRUITING

    Jizan, 82943, Saudi Arabia

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • St Pauls Hospital

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Sultan Qaboos University Hospital

    RECRUITING

    Muscat, Sultanet of Oman/Muscat/Al Khoud, 123, Oman

  • Suretech Hospital and Research Centre Ltd.

    NOT_YET_RECRUITING

    Maharashtra, 440012, India

  • Texas Children's Hospital_Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • The Hospital for Sick Children

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • UCSF Oakland Benioff ChildHosp

    ACTIVE_NOT_RECRUITING

    Oakland, California, 94609, United States

  • UCSF Oakland Benioff ChildHosp

    RECRUITING

    Oakland, California, 94609, United States

  • UT Health University of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Univ of Alabama Birmingham

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233, United States

  • Univ of Miami/SCCC

    COMPLETED

    Miami, Florida, 33136, United States

  • Univer Of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University College Hospital Paediatric Haematology and Oncology Unit, Ibadan

    NOT_YET_RECRUITING

    Ibadan, Oyo State, 0000, Nigeria

  • University Health Network - Toronto General Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Of California Irvine

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • University of Abuja Teaching Hospital, Gwagwalada, Abuja

    NOT_YET_RECRUITING

    Abuja, 228, Nigeria

  • University of Connecticut

    ACTIVE_NOT_RECRUITING

    Farmington, Connecticut, 06030, United States

  • University of Nigeria Teaching Hospital (UNTH)

    NOT_YET_RECRUITING

    Ituku-Ozalla, Enugu State, 400001, Nigeria

  • Universitätsklinikum Freiburg - Kinder- und Jugendklinik

    COMPLETED

    Freiburg im Breisgau, 79106, Germany

  • VM Medical Park Mersin Hastanesi- Hematoloji

    NOT_YET_RECRUITING

    Mersin, 33200, Turkey (Türkiye)

  • Versiti, CCBD_Milwaukee

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Victoria Hospital, Bangalore

    NOT_YET_RECRUITING

    Bangalore, 560002, India

  • Virginia Comm Univ Medical Ctr

    COMPLETED

    Richmond, Virginia, 23298, United States

  • Washington University-St.Louis

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Med Coll-NYPH

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • Zagazig University Hospital

    RECRUITING

    Alsharkia, Egypt, 44519, Egypt

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