GBT021601 for Sickle Cell Disease

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?An Open-label Extension Study of GBT021601 in Participants with Sickle Cell Disease

Eligibility Criteria

This trial is for males and females aged 6 months or older with Sickle Cell Disease who were part of a previous GBT021601 study. They must use effective contraception if sexually active, have provided consent, and not have withdrawn from the earlier study. Those who recently used voxelotor or were noncompliant are excluded.

Inclusion Criteria

I will use barrier contraception methods for 120 days after my last dose.

Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirements

I am using reliable birth control methods during and for 4 months after the study.

+3 more

Exclusion Criteria

Participant withdrew consent or was noncompliant from the originating GBT021601 clinical study

I have taken voxelotor within the last 10 days.

Participant Groups

The trial is testing an open-label drug called GBT021601 in participants with Sickle Cell Disease to see its long-term effects. It's an extension of a prior study where participants continue receiving this medication.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Osivelotor