RecruitingPhase 2Phase 3NCT05431088

A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD

A PHASE 2/3 RANDOMIZED, MULTICENTER STUDY OF OSIVELOTOR ADMINISTERED ORALLY TO ADULT AND ADOLESCENT PARTICIPANTS WITH SICKLE CELL DISEASE


Sponsor

Pfizer

Enrollment

389 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Osivelotor for people with sickle cell disease. The study is currently recruiting participants at 49 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsivelotor

Tablets which contain drug substance


Locations(80)

AMR Clinical

Mobile, Alabama, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Smilow Cancer Hospital

New Haven, Connecticut, United States

Edward Jenner Research Group 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

Children's Center for Advanced Pediatrics

Atlanta, Georgia, 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

Children's Hospital of Michigan

Detroit, Michigan, United States

Great Lakes Research Institute, Flourish Detroit

Southfield, Michigan, United States

Southern Specialty Research

Flowood, Mississippi, United States

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States

University Health

Kansas City, Missouri, United States

Jack & Sheryl Morris Cancer Center

New Brunswick, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Jacobi Medical Center

The Bronx, New York, 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

Duke University IDS Pharmacy

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

ECU Physicians, Brody Outpatient Clinic

Greenville, North Carolina, United States

UNC IDS

Morrisville, North Carolina, United States

Prisma Health Laurens County Hospital

Clinton, South Carolina, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Prisma Health Outpatient Radiology - Greenville

Greenville, South Carolina, United States

Prisma Health Patewood Hospital

Greenville, South Carolina, United States

Prisma Health Greer Memorial Hospital

Greer, South Carolina, United States

Prisma Health Hillcrest Hospital

Simpsonville, South Carolina, United States

Prisma Health North Greenville Hospital

Travelers Rest, South 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

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

CPHosp Medicina, Ensino e Pesquisa Ltda

São, 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

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

AIIMS Raipur

Raipur, Chhattisgarh, India

Nirmal Hospital Pvt Ltd

Surat, Gujarat, India

Haemato Oncology Care Centre

Vadodara, Gujarat, India

Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute

Nashik, Maharashtra, India

AIIMS Delhi

New Delhi, National Capital Territory of Delhi, India

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 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

King Khalid University Hospital

Riyadh, Riyadh Region, Saudi Arabia

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

Bristol Royal Infirmary

Bristol, United Kingdom

University College London Hospital

London, United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

Hammersmith Hospital

London, United Kingdom

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NCT05431088


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