A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
Mostrando el original en inglés
A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
Fase
PHASE2
Inscripción
95 (estimado)
Rango de edad
6 Months to 18 Years
Sexo
ALL
Resumen
This study is being done to learn about etavopivat, a once a day medicine taken by mouth in adolescents with sickle cell disease. The main goals are to study safety and how long etavopivat stays in the bloodstream, while also studying if there are benefits from taking etavopivat. Eligible participants who enter the study will start a 96-week treatment period. At the end of the 96 weeks, participants will have an end of study visit that occurs 4 weeks later. The participants will receive etavopivat every day throughout the treatment period.
Mostrando el original en inglés
Afecciones estudiadas
Período de inscripción
12 ene 2023 – finalización estimada 23 feb 2028
Patrocinadores
Ubicaciones del estudio
The Hospital for Sick Children
Toronto, Ontario
APHP - Centre de Référence des Syndromes
Paris
Hospices Civils de Lyon-Hopital Lyon Sud
Pierre-Bénite
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Roeun
KEMRI-Walter-Reed Kericho
Kericho
Kombewa Clinical Research Centre
Kisumu
Ahero Clinical Trials Unit
Kisumu
Kenya Medical Research Institute-Centre for Respiratory Disease Research, Siaya Clinical Research Annexe
Siaya
American University of Beirut Medical center
Beirut
Hospital Nini
Tripoli
University of Nigeria Teaching Hospital (UNTH)
Ituku-Ozalla, Enugu State
Lagos University Teaching Hospital, Lagos
Lagos
Aminu Kano Teaching Hospital (AKTH)
Tarauni
Hacettepe University pediatric hematology
Ankara
Acıbadem Adana Hastanesi
Seyhan
Guys and St Thomas NHS Foundation Trust / Evelina Childrens Hospital
London
King's College Hospital - Alex Mowat Research Hub
London
Manchester Royal Infirmary_1
Manchester