An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants With Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials

Locations

24 United States sites

6 United Kingdom sites

4 Egypt sites

3 Kenya sites

3 Turkey sites

2 Lebanon sites

2 Netherlands sites

1 Canada site

1 France site

1 Oman site

1 Italy site

Age

> 12 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease
Who Participated in Voxelotor Clinical Trials

participation requirements

– Male or female study participants with SCD who participated and received study
treatment in Study GBT440-031.

Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained
on study may be eligible for treatment in this study provided the AE does not pose a risk
for treatment with voxelotor.

– Females of child-bearing potential are required to have a negative urine pregnancy
test prior to dosing on Day 1.

– Female participants of child-bearing potential must use highly effective methods of
contraception to 30 days after the last dose of study drug. Male participants must use
barrier methods of contraception to 30 days after the last dose of study drug.

– Participant has provided written informed consent or assent (the ICF must be reviewed
and signed by each participant; in the case of pediatric participants, both the
consent of the participant’s legal representative or legal guardian, and the
participant’s assent must be obtained).

participation restrictions

– Female who is breast-feeding or pregnant.

– Participant withdrew consent from Study GBT440-031.

– Participant was lost to follow-up from Study GBT440-031.

– Participant requiring chronic dialysis.

– Any medical, psychological, safety, or behavioral conditions, which, in the opinion of
the Investigator, may confound safety interpretation, interfere with compliance, or
preclude informed consent.

Locations

  • Little Rock, Arkansas, United States, Arkansas Primary Care Clinic, PA, 72204
  • Oakland, California, United States, UCSF Benioff Children's Hospital Oakland, 94609
  • Miami, Florida, United States, University of Miami Medical Center, 33136
  • Atlanta, Georgia, United States, Emory University School of Medicine, 30342
  • Chicago, Illinois, United States, University of Illinois College of Medicine, 60612
  • Indianapolis, Indiana, United States, Indiana Hemophilia and Thrombosis Center, 46260
  • Baton Rouge, Louisiana, United States, Our Lady of the Lake Hospital, Inc., 70809
  • New Orleans, Louisiana, United States, University Medical Center New Orleans, 70112
  • Baltimore, Maryland, United States, The Johns Hopkins Hospital, 21287
  • Boston, Massachusetts, United States, Brigham and Women's Hospital Department of Neurology, 02115
  • Boston, Massachusetts, United States, Boston University Medical Center, 02118
  • Detroit, Michigan, United States, Wayne State University, 48201
  • Newark, New Jersey, United States, Newark Beth Israel Medical Center, 07112
  • Bronx, New York, United States, Montefiore Medical Center, 10467
  • New York, New York, United States, Columbia University Medical Center, 10032
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill, 27599
  • Durham, North Carolina, United States, Duke University, 27710
  • Oklahoma City, Oklahoma, United States, Lynn Health Science Institute, 73112
  • Philadelphia, Pennsylvania, United States, Thomas Jefferson University Hospital, 19107
  • Pittsburgh, Pennsylvania, United States, University of Pittsburgh Medical Center Health System, 15232
  • Charleston, South Carolina, United States, Medical University of South Carolina, 29425
  • Memphis, Tennessee, United States, Methodist Healthcare Foundation, 38104
  • Houston, Texas, United States, Texas Children's Hospital, 77030
  • Richmond, Virginia, United States, VCU Health - Research Parent, 23298
  • Toronto, Ontario, Canada, University Health Network, M5G 2C4
  • Al Sharkeya, Egypt, Zagazig University Hospital, 44519
  • Alexandria, Egypt, Alexandria University Hospital, 21131
  • Cairo, Egypt, Cairo University Hospital- Abou El Rish, 00000
  • Cairo, Egypt, Ain Shams University Hospital, 11566
  • Paris, France, Hôpital Européen Georges Pompidou, 75015
  • Padova, Italy, Azienda Ospedaliera di Padova, 35128
  • Nairobi, Kenya, Gertrude's Children's Hospital, 00200
  • Nairobi, Kenya, KEMRI - Centre for Respiratory Disease Research (CRDR), 00200
  • Siaya, Kenya, KEMRI (Kenya Medical Research Institute) Kisumu, 144 - 40600
  • Beirut, Lebanon, American University of Beirut Medical Center, 1107 2020
  • Tripoli, Lebanon, Nini Hospital s a l, 1434
  • Amsterdam, Netherlands, Amsterdam UMC, Locatie AMC, 1105 AZ
  • Rotterdam, Netherlands, Erasmus Medisch Centrum, 3015 CE
  • Muscat, Oman, Sultan َQaboos University Hospital, 123
  • Adana, Turkey, Acibadem Adana Hospital, 01130
  • Kayseri, Turkey, Erciyes University Medical Faculty, 38039
  • Mersin, Turkey, Mersin University Medical Faculty, 33079
  • London, Greater London, United Kingdom, Royal London Hospital, E1 1BB
  • London, Greater London, United Kingdom, Homerton University Hospital, E9 6SR
  • London, Greater London, United Kingdom, St Thomas' Hospital, SE1 7EH
  • London, Greater London, United Kingdom, King's College Hospital, SE5 9NU
  • London, Greater London, United Kingdom, University College London Hospitals, WC1N 3BG
  • London, United Kingdom, Hammersmith Hospital, W12 0HS