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A Phase 2/3 Study in Adult and Adolescent Participants With SCD
Sponsor: Pfizer
Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Official title: A Phase 2/3 Randomized, Multicenter Study of Osivelotor Administered Orally to Adult and Adolescent Participants With Sickle Cell Disease
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
389
Start Date
2022-09-22
Completion Date
2032-12-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Osivelotor
Tablets which contain drug substance
Locations (49)
Smilow Cancer Hospital
New Haven, Connecticut, United States
Edward Jenner Research Group Center LLC
Plantation, Florida, United States
Pediatric Hematology / Oncology a division of Kidz Medical services
West Palm Beach, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Alpha Clinical Research Georgia
Dunwoody, Georgia, United States
Sonar Clinical Research
Riverdale, Georgia, United States
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS)
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana, United States
Our lady of the Lake Hospital
Baton Rouge, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
University Health
Kansas City, Missouri, United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
UNC Health
Chapel Hill, North Carolina, United States
UNC Eastowne Medical Office Building - Consent Only
Chapel Hill, North Carolina, United States
UNC IDS
Morrisville, North Carolina, United States
McGovern Medical School at UTHealth
Houston, Texas, United States
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
UT Physicians Comprehensive Sickle Cell Clinic
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Hospital Universitario Professor Edgar Santos
Salvador, Estado de Bahia, Brazil
Multihemo Servicos Medicos S/A
Recife, Pernambuco, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
BP A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo, Brazil
Esho Empresa de Servicos Hospitalares S A
São Paulo, SÃO Paulo- Brasil, Brazil
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, Brazil
Esho Empresa de Servicos Hospitalares S A
São Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Nirmal Hospital Pvt Ltd
Surat, Gujarat, India
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra, India
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
Kisumu, Siaya County, Kenya
Gertrude's Children's Hospital
Nairobi, Kenya
Kenya Medical Research Institute - Centre for Respiratory Disease Research
Nairobi, Kenya
Center for Research In Therapeutic Sciences (CREATES), Strathmore University Medical Centre
Nairobi, Kenya
University College Hospital Ibadan
Ibadan, Oyo/ibadan North, Nigeria
Aminu Kano Teaching Hospital
Kano, Nigeria
Lagos University Teaching Hospital
Lagos, Nigeria
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom