Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1301-8130 | Other Identifier | Universal Trial Number | |
| 2024-510805-27 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants greater than or equal to (≥) 12 years old with sickle cell disease | Experimental | Participants will receive an oral dose of Etavopivat A or C. |
|
| Participants ≥ 12 years old with sickle cell disease transfusion dependent | Experimental | Participants will receive an oral dose of Etavopivat A or C. |
|
| Participants ≥ 12 years old with transfusion-dependent thalassaemia | Experimental | Participants will receive an oral dose of Etavopivat A or C. |
|
| Participants ≥ 12 years old with non-transfusion dependent thalassaemia | Experimental | Participants will receive an oral dose of Etavopivat A or C. |
|
| Participants ≥ 2 years to less than (<) 12 years old with sickle cell disease | Experimental | Participants ≥ 12 years of age will receive an oral dose of Etavopivat A or C and participants < 12 years of age will receive an oral dose of Etavopivat B. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etavopivat A | Drug | Participants will receive an oral dose of Etavopivat A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately | Measured as number of events. | Baseline (week 0 of FLORAL) up to end of study (up to week 316) |
| Number of adverse reactions, reported for each indication and age group separately | Measured as number of adverse reactions. | Baseline (week 0 of FLORAL) up to end of study (up to week 316) |
| Measure | Description | Time Frame |
|---|---|---|
| Annualised vaso-occlusive crisis (VOC) rates, reported for each age group separately | Measured as count. | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) |
| Change in VOCs, reported for each age group separately |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama Birmingham | Active, not recruiting | Birmingham | Alabama | 35233 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Etavopivat B | Drug | Participants will receive an oral dose of Etavopivat B. |
|
| Etavopivat C | Drug | Participants will receive an oral dose of Etavopivat C. |
|
Measured as count.
| Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) |
| Change in hemoglobin (Hb) concentration, reported for each age group separately | Measured as grams per deciliter (g/dL). | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) |
| Annualised number of hospitalisations, reported for each age group separately | Measured as count. | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) |
| Average length of stay of hospitalisations, reported for each age group separately | Measured as days. | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) |
| Change in Hb concentration | Measured as g/dL. | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) |
| Number of red blood cell (RBC) units transfused, reported for each indication separately | Measured as units. | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) |
| Change in RBC units transfused, reported for each indication separately | Measured as units. | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) |
| Phoenix Children's Hsptl |
| Recruiting |
| Phoenix |
| Arizona |
| 85016 |
| 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 |
| UCSF Oakland Benioff ChildHosp | Active, not recruiting | Oakland | California | 94609 | United States |
| UCSF Oakland Benioff ChildHosp | Recruiting | Oakland | California | 94609 | United States |
| Children's Hosp Of Orange | Completed | Orange | California | 92868 | United States |
| University Of California Irvine | Recruiting | Orange | California | 92868 | United States |
| University of Connecticut | Active, not recruiting | Farmington | Connecticut | 06030 | United States |
| Children's National Medical Center | Completed | Washington D.C. | District of Columbia | 20010 | United States |
| Foundation for Sickle Cell Disease Research | Recruiting | Hollywood | Florida | 33023 | United States |
| Univ of Miami/SCCC | Completed | Miami | Florida | 33136 | United States |
| Emory University School of Medicine | Active, not recruiting | Atlanta | Georgia | 30303 | United States |
| Children's Healthcare Atlanta | Recruiting | Atlanta | Georgia | 30329 | United States |
| Center for Blood Disorders Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
| Univer Of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Children's Hosp-New Orleans | Completed | New Orleans | Louisiana | 70118 | United States |
| Boston Medical Center | Active, not recruiting | Boston | Massachusetts | 02118 | United States |
| Washington University-St.Louis | Recruiting | St Louis | Missouri | 63110 | United States |
| NYC Health+Hospitals | Recruiting | Brooklyn | New York | 11203 | 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 |
| Weill Cornell Med Coll-NYPH | Recruiting | New York | New York | 10065 | United States |
| Jacobi Medical Center | Active, not recruiting | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| Atrium Levine Children's/Atrium Health | Not yet recruiting | Charlotte | North Carolina | 28204 | United States |
| Duke University_Durham | Recruiting | Durham | North Carolina | 27705 | 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 |
| Atrium Health-Wake Forest Bapt | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Child's Hsp Med Ctr | Active, not recruiting | Cincinnati | Ohio | 45229 | United States |
| Neuro-Behavioral Clinical Research | Active, not recruiting | North Canton | Ohio | 44720 | United States |
| Medical University Of South Carolina_Charleston | Recruiting | Charleston | South Carolina | 29425 | United States |
| Methodist University Hospital | Recruiting | Memphis | Tennessee | 38104 | United States |
| Texas Children's Hospital_Houston | Recruiting | Houston | Texas | 77030 | United States |
| UT Health University of Texas | Recruiting | Houston | Texas | 77030 | United States |
| Virginia Comm Univ Medical Ctr | Recruiting | Richmond | Virginia | 23298 | United States |
| Mary Bridge Children's Health | Active, not recruiting | Tacoma | Washington | 98405 | United States |
| Versiti, CCBD_Milwaukee | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| St Pauls Hospital | Active, not recruiting | Vancouver | British Columbia | V6Z1Y6 | Canada |
| The Hospital for Sick Children | Active, not recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| University Health Network - Toronto General Hospital | Active, not recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| CHU Ste-Justine | Active, not recruiting | Montreal | Quebec | H3T 1C5 | Canada |
| Alexandria University Hospital | Not yet recruiting | Alexandria, Egypt | 21131 | Egypt |
| Zagazig University Hospital | Not yet recruiting | Alsharkia, Egypt | 44519 | Egypt |
| Faculty of Medicine Ain Shams Medical Research Institute (MASRI) | Not yet recruiting | Cairo | 1181 | Egypt |
| Cairo University | Recruiting | Cairo, Egypt | 11956 | Egypt |
| Abu El-Reesh El-Mounira Children University Hospital | Recruiting | Cairo, Egypt | 4241317 | Egypt |
| Ap-Hp-Hopital Henri Mondor | Recruiting | Créteil | 94000 | France |
| Hospices Civils de Lyon-Hopital Edouard Herriot | Recruiting | Lyon | 69437 | France |
| Ap-Hp-Hopital Robert Debre | Recruiting | Paris | 75019 | France |
| Ap-Hp-Hopital Robert Debre | Not yet recruiting | Paris | 75019 | France |
| Charité - Campus Virchow-Klinikum - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie | Not yet recruiting | Berlin | 13353 | Germany |
| Universitätsklinikum Freiburg - Kinder- und Jugendklinik | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Kintampo Health Research Centre (KHRC) | Not yet recruiting | Kintampo | Bono East | 27WF+98M | Ghana |
| Ghana Institute of Clinical Genetics, Korle Bu Teaching Hospital (KBTH) | Not yet recruiting | Accra | 0 | Ghana |
| General Hospital Of Larissa Koutlibaneio And Triantafylleio - Thalassemia and SCD Unit | Recruiting | Larissa | Thessaly | 41221 | Greece |
| Hippokration Hospital | Recruiting | Athens | 11527 | Greece |
| General University Hospital of Patras | Recruiting | Pátrai | 26504 | Greece |
| 'Ippokrateio' General Hospital of Thessaloniki | Recruiting | Thessaloniki | 54642 | Greece |
| All India Institute of Medical Sciences (AIIMS), Raipur | Not yet recruiting | Raipur | Chhattisgarh | 492099 | India |
| K.J Somaiya Hospital and Research Centre | Not yet recruiting | Mumbai | Maharashtra | 400022 | India |
| Victoria Hospital, Bangalore | Not yet recruiting | Bangalore | 560002 | India |
| Nirmal Hospital Pvt. Ltd. | Not yet recruiting | Gujarat | 395002 | India |
| Suretech Hospital and Research Centre Ltd. | Not yet recruiting | Maharashtra | 440012 | India |
| All India Institute of Medical Sciences_Delhi | Not yet recruiting | New Delhi | 110029 | India |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche | Recruiting | Orbassano | Torino | 10043 | Italy |
| Azienda Ospedale Universita Padova | Recruiting | Padova | 35128 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
| Gertrude's Children's Hospital | Recruiting | Nairobi | Nairobi County | 00509 | Kenya |
| KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital | Not yet recruiting | Siaya | Siaya County | 40600 | Kenya |
| KEMRI-Walter-Reed Kericho | Not yet recruiting | Kericho | 20200 | Kenya |
| Kombewa Clinical Research Centre | Not yet recruiting | Kisumu | 1932 | Kenya |
| KEMRI Kondele Children Hospital, Kisumu | Recruiting | Kisumu | 40100 | Kenya |
| Ahero Clinical Trials Unit | Recruiting | Kisumu | 40101 | Kenya |
| American University of Beirut Medical Centre | Recruiting | Hamra | 11-0236 | Lebanon |
| Chronic Care Center | Recruiting | Hazmiyeh | 21211 | Lebanon |
| Hospital Nini | Recruiting | Tripoli | 1434 | Lebanon |
| University of Nigeria Teaching Hospital (UNTH) | Not yet recruiting | Ituku-Ozalla | Enugu State | 400001 | Nigeria |
| University College Hospital Paediatric Haematology and Oncology Unit, Ibadan | Not yet recruiting | Ibadan | Oyo State | 0000 | Nigeria |
| University of Abuja Teaching Hospital, Gwagwalada, Abuja | Not yet recruiting | Abuja | 228 | Nigeria |
| Barau Dikko Teaching Hospital, Kaduna | Not yet recruiting | Kaduna | 800212 | Nigeria |
| Aminu Kano Teaching Hospital (AKTH) | Not yet recruiting | Kano | 3452 | Nigeria |
| Lagos University Teaching Hospital, Lagos | Not yet recruiting | Lagos | 102215 | Nigeria |
| Sultan Qaboos University Hospital | Recruiting | Muscat | Sultanet of Oman/Muscat/Al Khoud | 123 | Oman |
| Prince Mohammad Bin Naser Hospital | Not yet recruiting | Jizan | 82943 | Saudi Arabia |
| King Khalid University Hospital | Recruiting | Riyadh | 12372 | Saudi Arabia |
| Hospital Universitario de Cruces | Active, not recruiting | Barakaldo | 48903 | Spain |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Baskent Universitesi Adana | Not yet recruiting | Adana | 01250 | Turkey (Türkiye) |
| Başkent Üniversitesi Adana-Hematoloji | Recruiting | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe University Hematology | Not yet recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Hacettepe Üniversitesi Hastanesi- Hematoloji | Not yet recruiting | Ankara | 06230 | Turkey (Türkiye) |
| 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) |
| VM Medical Park Mersin Hastanesi- Hematoloji | Not yet recruiting | Mersin | 33200 | Turkey (Türkiye) |
| Evelina London Children's Hospital - Haemophilia | Not yet recruiting | London | SE1 7EH | United Kingdom |
| Guy's Hospital - Haematology | Recruiting | London | SE1 9RT | United Kingdom |
| Guy's Hospital | Not yet recruiting | London | SE1 9RT | United Kingdom |
| King's College Hospital - Paediatric Research | Recruiting | London | SE5 9RS | United Kingdom |
| Kings College Hospital - Haematology | Recruiting | London | SE5 9RS | United Kingdom |
| Imperial College London | Recruiting | London | W12 0NN | United Kingdom |
| Manchester Royal Infirmary | Recruiting | Manchester | M13 9WL | United Kingdom |
| Royal Hallamshire Hospital | Recruiting | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided