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Open-Label Extension of Voxelotor
Open-Label Extension of Voxelotor

NCT04188509

TerminatedPhase 3

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: Voxelotor

Countries: United States, Egypt, Lebanon, Nigeria, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 6 Months to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
Locations (20)
  • Washington D.C., District of Columbia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Kansas City, Missouri, United States
  • Greenville, North Carolina, United States
  • Pittsburgh, Pennsylvania, United States
  • Zagazig, Alsharkia, Egypt
  • Alexandria, Egypt
  • Cairo, Egypt
  • Cairo, Egypt
  • Beirut, Lebanon
  • Tripoli, Lebanon
  • Calabar, Cross River State, Nigeria
  • Ibadan, Oyo State, Nigeria
  • Kaduna, Nigeria
  • Kano, Nigeria
  • Lagos, Nigeria
  • London, Greater London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom