A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
About this study
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
- Condition
- Sickle Cell Disease
- Tested
- Osivelotor
- Sponsor
- Pfizer
Who can join
- Age
- 12 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 12 years
- Study condition: Sickle Cell Disease
- Part A and Part B:
- Male or female with SCD, HbSS and HbSB-zero
- Participants with Hemoglobin ≥ 5.5 and ≤ 10.5 g/dL during Screening and considered stable 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 need for dose adjustments during the study in the opinion of the Investigator.
- Part B:
- Participants with SCD ages 12 years and older, inclusive at screening.
- Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.
- \- Participants who have completed the Part B successfully will be eligible.
Exclusion 9
- Part A and Part B:
- Participants who had more than 10 VOC within 12 months of screening
- Female participant who is breastfeeding or pregnant
- Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1
- Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or anytime during the screening period.
- Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months.
- Have any unresolved clinically significant adverse event, laboratory abnormality, or safety finding from Part B that, in the opinion of the Investigator, increases the risk of study drug administration.
- Met permanent treatment discontinuation criteria during Part B.
- Have withdrawn consent or are unable to comply with study procedure
Where
80 sites, 60 recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra, India
Nirmal Hospital Pvt Ltd
Surat, Gujarat, India
Haemato Oncology Care Centre
Vadodara, Gujarat, India
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
and 74 more sites on ClinicalTrials.gov
Contact
-
Pfizer Pfizer CT.gov Call Center
1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Potential match only. Final eligibility is determined by the study team.