Studie hodnotící účinnost a bezpečnost mitapivatu u účastníků s alfa- nebo beta-talasémií (α- nebo β-TDT) závislou na transfuzi (ENERGIZE-T)
Fáze 3, dvojitě zaslepená, randomizovaná, placebem kontrolovaná, multicentrická studie hodnotící účinnost a bezpečnost mitapivatu u pacientů s alfa- nebo beta-talasémií závislou na transfuzi (ENERGIZE-T)
The primary objective of this study was to compare the effect of mitapivat versus placebo on transfusion burden in participants with α- or β-transfusion-dependent thalassemia.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
The mitapivat group included 171 participants. The placebo group included 87 participants.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Ribeirão Preto, Brazílie, 14051-260
- Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
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São Paulo, Brazílie, 04006-002
- GSH Banco de Sangue de São Paulo
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Kyustendil, Bulharsko, 2500
- MHAT "Dr. Nikola Vasiliev" AD
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Pleven, Bulharsko, 5800
- UMHAT "Dr. Georgi Stranski" Pleven
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Plovdiv, Bulharsko, 4002
- UMHAT "Sveti Georgi" EAD
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Sofia, Bulharsko, 1756
- SHATHD Sofia
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Stara Zagora, Bulharsko, 6000
- UMHAT "Prof. Dr. Stoyan Kirkovich"
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Hovedstaden, Dánsko, 2100
- Rigshospitalet
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Créteil, Francie, 94010
- CHU Hôpital Henri Mondor
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Lyon, Francie, 69003
- Hôpital Edouard Herriot, CHU de Lyon
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Marseille, Francie, 13385
- CHU Hôpital de la Timone
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Paris, Francie, 75015
- Hôpital Necker Enfants Malades
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Amsterdam, Holandsko, 1105 AZ
- Amsterdam Universitair Medisch Centrum, Locatie AMC
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Utrecht, Holandsko, 3584 CX
- Universitair Medisch Centrum Utrecht
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Westzeedijk 353, Holandsko, 3015 AA
- Erasmus MC
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Brindisi, Itálie, 72100
- Ospedale "A. Perrino" - Brindisi
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Cagliari, Itálie, 09121
- Ospedale Pediatrico Microcitemico
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Ferrara, Itálie, 44124
- Ospedale Sant'Anna
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Genova, Itálie, 16128
- Ente Ospedaliero Ospedali Galliera
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Milan, Itálie, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Modena, Itálie, 41124
- A.O.U Di Modena
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Naples, Itálie, 80138
- AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
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Orbassano, Itálie, 10043
- A.O.U. San Luigi Gonzaga
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Alberta
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Calgary, Alberta, Kanada, T2N 2T9
- Foothills Medical Centre
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Ontario
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Toronto, Ontario, Kanada, M5G 2C4
- Toronto General Hospital, University Health Network
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Beirut, Libanon, 9999
- Chronic Care Center
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Alor Star, Malajsie, 05460
- Hospital Sultanah Bahiyah
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Johor Bahru, Malajsie, 80100
- Hospital Sultanah Aminah Johor Bahru
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Kota Kinabalu, Malajsie, 88586
- Hospital Queen Elizabeth, Kota Kinabalu
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Kuala Lumpur, Malajsie, 50300
- Hospital Tunku Azizah
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Kuantan, Malajsie, 25100
- Hospital Tengku Ampuan Afzan
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Kuching, Malajsie, 93586
- Hospital Umum Sarawak
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Pandan Indah, Malajsie, 68000
- Hospital Ampang
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Pulau Pinang, Malajsie, 10990
- Hospital Pulau Pinang
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Berlin, Německo, 13353
- Charité - UB - CVK - Medizinische Klinik
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Essen, Německo, 45122
- Universitätsklinikum Essen
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Leipzig, Německo, 04103
- Universitätsklinikum Leipzig
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Riyadh, Saudská arábie, 14611
- King Abdullah International Medical Research Center
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Riyadh, Saudská arábie, 90210
- King Khalid University Hospital
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Abu Dhabi, Spojené arabské emiráty
- Burjeel Medical City
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London, Spojené království, WC1E 6BT
- University College London
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London, Spojené království, W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Arizona
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Phoenix, Arizona, Spojené státy, 85016-7710
- Phoenix Children's Hospital
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California
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La Jolla, California, Spojené státy, 92093
- San Diego Hospital, UC San Diego Health
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Oakland, California, Spojené státy, 94609-1809
- Children's Hospital Oakland
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Palo Alto, California, Spojené státy, 94304-1601
- Stanford Medicine
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Boston Children's Hospital
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Michigan
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Detroit, Michigan, Spojené státy, 48201-2196
- Children's Hospital of Michigan
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New York
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New York, New York, Spojené státy, 10065-4870
- Weill Cornell Medical Center
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North Carolina
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Durham, North Carolina, Spojené státy, 27710-3038
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Penn Medicine - University of Pennsylvania Health System
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Washington
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Seattle, Washington, Spojené státy, 98101
- Seattle Cancer Care Alliance, University of Washington
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Taipei, Tchaj-wan, 100
- National Taiwan University Hospital
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Bangkok, Thajsko, 10400
- Phramongkutklao Hospital
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Bangkok, Thajsko, 10400
- Ramathibodi Hospital
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Bangkok, Thajsko, 10700
- Faculty of Medicine Siriraj Hospital
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Chiang Mai, Thajsko, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Khon Kaen, Thajsko, 40000
- Srinagarind Hospital, Khon Kaen University
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Mueang Phitsanulok, Thajsko, 65000
- Naresuan University Hospital
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Pathum Wan, Thajsko
- King Chulalongkorn Memorial Hospital
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Adana, Turecko (Türkiye), 1130
- Acibadem Adana Hospital
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Antalya, Turecko (Türkiye), 07059
- Akdeniz University Faculty of Medicine
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Balcalı, Turecko (Türkiye), 01330
- Çukurova University
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Bornova, Turecko (Türkiye), 35040
- Ege University Faculty of Medicine
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Fatih, Turecko (Türkiye), 34093
- Istanbul University Faculty of Medicine
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Mersin, Turecko (Türkiye)
- Hacettepe University
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Achaia, Řecko, 26504
- University General Hospital of Patras
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Athens, Řecko, 11527
- Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School
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Athens, Řecko, 115 26
- Laiko General Hospital
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Ioannina, Řecko, 455 00
- University Hospital of Ioannina
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Thessaloniki, Řecko, 546 42
- Ippokrateio General Hospital
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Barcelona, Španělsko, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Murcia, Španělsko, 30120
- Hospital Universitario Virgen Arrixaca
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Seville, Španělsko, 41013
- Hospital Universitario Virgen del Rocío
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Greater than or equal to (≥)18 years of age at the time of providing informed consent;
- Documented diagnosis of thalassemia (β-thalassemia with or without α-globin gene mutations, hemoglobin E (HbE)/β-thalassemia, or α-thalassemia/hemoglobin H (HbH) disease) based on deoxyribonucleic acid (DNA) analysis;
- Considered transfusion-dependent, defined as 6 to 20 red blood cells (RBC) units transfused and ≤6-week transfusion-free period during the 24-week period before randomization;
- If taking hydroxyurea, the hydroxyurea dose must be stable for ≥16 weeks before randomization;
- Women of childbearing potential (WOCBP) must be abstinent of sexual activities that may induce pregnancy as part of their usual lifestyle or agree to use two forms of contraception, one of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
- Written informed consent before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study.
Exclusion Criteria:
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Pregnant, breastfeeding, or parturient;
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Documented history of homozygous or heterozygous sickle hemoglobin (Hb S) or hemoglobin C (Hb C);
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Prior exposure to gene therapy or prior bone marrow or stem cell transplantation;
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Currently receiving treatment with luspatercept; the last dose must have been administered ≥36 weeks before randomization;
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Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered ≥36 weeks before randomization;
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History of malignancy (active or treated) ≤5 years before providing informed consent, except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;
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History of active and/or uncontrolled cardiac or pulmonary disease ≤6 months before providing informed consent;
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Hepatobiliary disorders;
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Estimated glomerular filtration rate <45 milliliters per minute (mL/min)/1.73 meter (m)^2 by Chronic Kidney Disease Epidemiology Collaboration creatinine equation;
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Nonfasting triglycerides >440 milligrams per deciliter (mg/dL) (5 millimoles per liter [mmol/L]);
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Active infection requiring systemic antimicrobial therapy at the time of providing informed consent;
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Positive test for hepatitis C virus antibody (HCVAb) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg);
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Positive test for human immunodeficiency virus (HIV)-1 antibody (Ab) or HIV-2 Ab;
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History of major surgery (including splenectomy) ≤6 months before providing informed consent and/or a major surgical procedure planned during the study;
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Current enrollment or past participation (≤12 weeks before administration of the first dose of study drug or a timeframe equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational treatment or device;
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Receiving strong CYP3A4/5 inhibitors that have not been stopped for ≥5 days or a timeframe equivalent to 5 half-lives (whichever is longer); or strong CYP3A4 inducers that have not been stopped for ≥4 weeks or a timeframe equivalent to 5 half-lives (whichever is longer), before randomization;
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Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed. The testosterone dose and preparation must be stable for ≥12 weeks before randomization;
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Known allergy, or other contraindication, to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate, Opadry® II Blue [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and Federal Food, Drug, and Cosmetic (FD&C) Blue #2]);
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Any medical, hematological, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:
- Participants who are institutionalized by regulatory or court order
- Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Mitapivat
Participants randomized to receive mitapivat 100 milligrams (mg), orally, twice daily (BID) for 48 weeks in the double-blind (DB) period and for up to 5 years in the open label extension (OLE) period. |
Tablets
Ostatní jména:
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Komparátor placeba: Placebo
Participants randomized to receive placebo matching mitapivat, orally, BID for 48 weeks in the DB period followed by mitapivat 100 mg, orally, BID for up to 5 years in the OLE period. |
Tablets
Ostatní jména:
Tablets |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Double-blind Period: Percentage of Participants Who Achieved Transfusion Reduction Response (TRR)
Časové okno: Double-blind Period: Baseline through Week 48
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TRR is defined as ≥50% reduction in transfused red blood cells (RBC) units with a reduction of ≥2 units of transfused RBCs in any consecutive 12-week period through Week 48 compared with baseline transfusion burden standardized to 12 weeks. Baseline transfusion burden standardized to 12 weeks= (12/24) × total number of RBC units transfused during 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 12 (Day 85) were considered nonresponders. |
Double-blind Period: Baseline through Week 48
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Dvojitá slepá doba: Plazmatické koncentrace mitapivatu
Časové okno: Dvojitá slepá doba: Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Dvojitá slepá doba: Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Dvojitá slepá doba: Maximální pozorovaná plazmatická koncentrace (CMAX) Mitapivatu
Časové okno: Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: čas na dosažení maximální pozorované koncentrace plazmy (TMAX) mitapivatu
Časové okno: Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: Čas poslední kvantifikovatelné koncentrace (Tlast) Mitapivatu
Časové okno: Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: Predace, 0,5, 1, 3, 5, 7 hodin po dávce 36
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Dvojitá slepá doba: Koncentrace krve adenosin trifosfátu (ATP)
Časové okno: Dvojitá slepá doba: Předběžná dávka v den 1; Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Dvojitá slepá doba: Předběžná dávka v den 1; Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Dvojitá slepá doba: Koncentrace krve 2,3-difosfoglycerátu (2,3-dpg)
Časové okno: Dvojitá slepá doba: Předběžná dávka v den 1; Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Dvojitá slepá doba: Předběžná dávka v den 1; Předběžná dávka ve 12. týdnu; předdávkování v 24. týdnu; předdatí, 0,5, 1, 3, 5, 7 hodin po dávce 36. týdne
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Double-blind Period: Percentage of Participants Who Achieved TRR2
Časové okno: Double-blind period: Baseline through Week 48
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TRR2, defined as a ≥50% reduction in transfused RBC units in any consecutive 24-week period through Week 48 compared with the 24-week baseline transfusion burden, is reported. Baseline transfusion burden standardized to 24 weeks is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 24 (Day 169) were considered nonresponders. |
Double-blind period: Baseline through Week 48
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Double-blind Period: Percentage of Participants Who Achieved TRR3
Časové okno: Double-blind period: Baseline up to Week 13 through Week 48
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TRR3, defined as a ≥33% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks= (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders. |
Double-blind period: Baseline up to Week 13 through Week 48
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Double-blind Period: Percentage of Participants Who Achieved TRR4
Časové okno: Double-blind period: Baseline up to Week 13 through Week 48
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TRR4, defined as a ≥50% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks = (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders. |
Double-blind period: Baseline up to Week 13 through Week 48
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Double-blind Period: Percent Change From Baseline in Transfused RBC Units
Časové okno: Double-blind Period: Baseline, Week 13 through Week 48
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Transfusion burden from Week 13 through Week 48 standardized to 36 weeks is defined as number of transfused RBC units from Day 85 through Week 48 in the Double-blind Period ×36/(Number of days from Day 85 through Week 48 in the Double-blind Period/7). Baseline transfusion burden standardized to 36 weeks= (36/24)× is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or within 168 days before the start of study treatment for participants randomized and dosed. |
Double-blind Period: Baseline, Week 13 through Week 48
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Double-blind Period: Percentage of Participants Who Achieved Transfusion-Independence
Časové okno: Double-blind Period: Baseline through Week 48
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Transfusion-independence is defined as transfusion-free for ≥8 consecutive weeks through Week 48 in the double-blind period. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Iron Levels
Časové okno: Double-blind Period: Baseline through Week 48
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Iron metabolism was assessed based on Iron levels. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Serum Ferritin Levels
Časové okno: Double-blind Period: Baseline through Week 48
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Iron metabolism was assessed based on serum ferritin levels. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Total Iron Binding Capacity
Časové okno: Double-blind Period: Baseline through Week 48
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Iron metabolism was assessed based on total iron binding capacity. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Transferrin Saturation (TSAT) Levels
Časové okno: Double-blind Period: Baseline through Week 48
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Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Časové okno: Double-blind Period: From first dose of study drug up to week 48
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Double-blind Period: From first dose of study drug up to week 48
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Open-label Extension Period: Number of Participants With TEAEs, Serious TEAEs, Related TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to 3
Časové okno: Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)
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Double-blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
Časové okno: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36
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Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule. |
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36
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Double-blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat
Časové okno: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36
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Clast is the last quantifiable concentration after a single dose or within the dosing interval (tau) for multiple doses. |
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Medical Affairs, Agios Pharmaceuticals, Inc.
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
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První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- AG348-C-018
- 2021-000212-34 (Číslo EudraCT)
- 2024-512747-23-00 (Ctis)
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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