A Phase 2/3 Study in Adult and Adolescent Participants With SCD
Recruiting
Phase 2
Phase 3
Interventional Study
Sickle Cell Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 389 (estimated)
- Sponsor
- Pfizer · Industry
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About This Trial
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Part A, Part B, and OLE:
* Male or female with SCD
* Participants with stable Hb value as judged by the Investigator
* For participants taking hydroxyurea and/or L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated…
Contacts