Phase
Condition
Sickle Cell Disease
Red Blood Cell Disorders
Treatment
open-label GBT021601
Osivelotor
Clinical Study ID
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 6 months or older with SCD who participated and received studydrug or placebo in a previous osivelotor clinical study and completed the end oftreatment visit. Note: Participants who discontinued study drug in the originating study due to anTEAE, but who remained on study, may be eligible for treatment in this studyprovided the TEAE does not pose a risk for treatment with osivelotor.
Females of childbearing potential are required to have a negative urine pregnancytest prior to dosing on Day 1. Note: Females who become of childbearing potential during the study must be willingto have negative urine pregnancy tests to remain in the study.
If sexually active, females of childbearing potential must consistently use highlyeffective methods of contraception consistently throughout the study and for atleast 120 days after the last dose of study drug. If sexually active, maleparticipants must use barrier methods of contraception until 84 days after the lastdose of study drug. Male participants are eligible to participate if they agree tothe following requirements during the study intervention period and for 84 daysafter the last dose of study intervention:
Refrain from donating sperm PLUS either
Be abstinent from heterosexual intercourse as their preferred and usuallifestyle OR
Must agree to use a male condom when engaging in any activity that allows forpassage of ejaculate to another person
- Participant has provided written informed consent/assent. For underage participants,both the consent of the participant's legal representative or legal guardian and theparticipant's assent (where applicable) must be obtained based on localrequirements.
Exclusion
Exclusion Criteria:
Participant withdrew consent or was noncompliant from the originating osivelotorclinical study
Current or recent use of voxelotor. Recent use is defined as within 10 days prior toDay 1
Current or recent use of crizanlizumab. Recent use is defined as within 90 daysprior to Day 1
Participant has any medical, psychological, safety, or behavioral conditions that,in the opinion of the Investigator, may confound safety interpretation, interferewith compliance, or preclude informed consent
Has received an investigational drug (including investigational vaccines) within 5times the elimination half-life (if known) or within 30 days (if the eliminationhalf-life- is unknown) prior to study drug administration or is concurrentlyenrolled in any research judged not to be scientifically or medically compatiblewith this study
Study Design
Study Description
Connect with a study center
College of Medicine, University of Ibadan
Ibadan, OYO State 200212
NigeriaSite Not Available
University College Hospital Ibadan
Ibadan, Oyo/ibadan North 200212
NigeriaSite Not Available
Aminu kano Teaching Hospital
Kano, 700233
NigeriaSite Not Available
Lagos University Teaching Hospital
Lagos, 100254
NigeriaSite Not Available
Edward Jenner Research Group LLC.
Miami, Florida 33317
United StatesSite Not Available
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana 70808
United StatesSite Not Available
University Medical Center Inpatient Pharmacy
New Orleans, Louisiana 70112
United StatesSite Not Available
University Medical Center New Orleans
New Orleans, Louisiana 70112
United StatesSite Not Available
Mississippi Center for Advanced Medicine
Madison, Mississippi 39110
United StatesSite Not Available
University of Texas Health Science Center
Houston, Texas 77030
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
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