Open-Label Extension of Voxelotor
Megadott ok: Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Key facts
- Where
- Atlanta, Chicago, Greenville, Kansas City, Pittsburgh és Washington D.C., Egyesült ÁllamokSee the 6 sites
- Phase
- 3. fázis
Where in Egyesült Államok
- Children's Healthcare of Atlanta, Scottish RiteAtlanta, Egyesült ÁllamokNo longer taking part
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Egyesült ÁllamokNo longer taking part
- ECU Physicians, Brody Outpatient ClinicGreenville, Egyesült ÁllamokNo longer taking part
- Children's Mercy HospitalKansas City, Egyesült ÁllamokNo longer taking part
- UPMC Children's Hospital of PittsburghPittsburgh, Egyesült ÁllamokNo longer taking part
- Children's National Medical CenterWashington D.C., Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04188509
- Record updated
- 2025. november 13.
- Original description
Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.Read full original descriptionShow less
An Open-Label Extension Study of Voxelotor Administered Orally to Participants With Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials
Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.
Inclusion: 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: Known hypersensitivity to voxelotor or any other components of the study drug; Female participant who is breastfeeding or pregnant; Participant withdrew consent from a GBT-sponsored voxelotor clinical study; 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.