Open-Label Extension of Voxelotor

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease

In brief

Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.

Key facts

Study ID

NCT04188509

Run by

Pfizer

People needed

162

Starts

2019-11-18

Expected to finish

2024-11-01

Last updated by the study team

2025-11-13

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant with SCD, who participated and received study drug in a GBT-sponsored voxelotor clinical study.
• Note: Participants 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.
• Note: Participants who discontinued Study GBT440-032 as the result of an abnormal transcranial Doppler (TCD) flow velocity assessment (≥ 200 cm/sec) are eligible for treatment in this study.
• Participant has provided written consent/assent (for pediatric participants, both the consent of the participant's legal representative or legal guardian and the participant's assent [where applicable] must be obtained).

You may not qualify if…

• Female participant who is breastfeeding or pregnant
• Participant withdrew consent from a GBT-sponsored voxelotor clinical study
• Known hypersensitivity to voxelotor or any other components of the study drug
• Use of St. John's wort, sensitive cytochrome P450 (CYP) 3A4 substrates with a narrow therapeutic index, or moderate or strong CYP3A4 inducers within 30 days of Day 1

Where it is running

• Ain Shams University Hospital - Clinical Research Center (MASRI-CRC) — Cairo, Egypt
• American University of Beirut - Medical Center — Beirut, Lebanon
• Nini Hospital — Tripoli, Lebanon
• University of Calabar Teaching Hospital — Calabar, Cross River State, Nigeria
• College of Medicine, University of Ibadan — Ibadan, Oyo State, Nigeria
• Barau Dikko Teaching Hospital/Kaduna State University — Kaduna, Nigeria
• Aminu Kano Teaching Hospital — Kano, Nigeria
• Lagos University Teaching Hospital — Lagos, Nigeria
• University College Hospital NHS Foundation Trust — London, Greater London, United Kingdom
• Barts Health NHS Trust , The Royal London Hospital — London, United Kingdom
• Guy'S and St Thomas' Nhs Foundation Trust — London, United Kingdom
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta Scottish Rite — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• ECU Physicians, Brody Outpatient Clinic — Greenville, North Carolina, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Zagazig University Hospital — Zagazig, Alsharkia, Egypt
• Alexandria University Hospital - Clinical Research Center — Alexandria, Egypt
• Cairo University Hospital, Abu El Rish Hospital — Cairo, Egypt

Full record on ClinicalTrials.gov

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