Last updated: Month X, 2022
Condition
Sickle Cell Disease
Age
16 and Older
Countries
17 Countries
Status
Actively Recruiting
In this study, researchers are looking at the safety and efficacy of inclacumab, a potential treatment related to sickle cell disease (SCD). Clinical studies are conducted to learn about the effects of investigational drugs. The studies are the most important way researchers can confirm that a new drug or treatment is safe and effective.
Inclacumab is an investigational study drug related to sickle cell disease.
The THRIVE-131, phase 3 study will assess the safety and efficacy
of
inclacumab, a P-selectin
inhibitor, in
approximately 240 adult and adolescent participants (≥ 16 years of age) with SCD. Participants
will be randomized to
receive inclacumab or placebo.
Eligible participants will be administered inclacumab or
placebo
intravenous (IV) every
12 weeks.
The total duration of treatment for each participant will be 48 weeks.
Participants
that complete the study
through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE)
study.*
*Please contact THRIVEstudy@gbt.com if you have any questions.
Inclacumab is an investigational study drug related to sickle cell disease.
Am
I eligible?
Study Duration:
October 2021 to October 2023
Total Duration per
Participant:
48 weeks
CONNECTICUT
University of Connecticut
Farmington, CT 06030
GBT2104-131
GBT2104-131
WASHINGTON, DC
Children's National Hospital
Washington, DC 20010
GBT2104-131
GBT2104-131
MASSACHUSETTS
Brigham and Women’s Hospital
Boston, MA 02215
GBT2104-131
GBT2104-131
NEW YORK
Jacobi Medical Center
Bronx, NY 10461
GBT2104-131
GBT2104-131
NEW YORK
Erie County Medical Center
Buffalo, NY 14215
GBT2104-131
GBT2104-131
ILLINOIS
University of Illinois at Chicago
Chicago, IL 60612
GBT2104-131
GBT2104-131
ILLINOIS
Rush University Medical Center
Chicago, IL 60612
GBT2104-131
GBT2104-131
MICHIGAN
University of Michigan
Ann Arbor, MI 48109
GBT2104-131
GBT2104-131
ALABAMA
University of South Alabama Children's and Women's Hospital
Mobile, AL 36604
GBT2104-131
GBT2104-131
ARKANSAS
Arkansas Children's Hospital
Little Rock, AR 72202
GBT2104-131
GBT2104-131
FLORIDA
University of South Florida
Tampa, FL 33606
GBT2104-131
GBT2104-131
NORTH CAROLINA
Duke University Medical Center
Durham, NC 27710
GBT2104-131
GBT2104-131
TENNESSEE
St Jude Children's Research Hospital
Memphis, TN 38105
GBT2104-131
GBT2104-131
TEXAS
University of Texas Health Science Center at Houston
Houston, TX 77030
GBT2104-131
GBT2104-131
ARIZONA
Phoenix Children’s Hospital
Phoenix, AZ 85016
GBT2104-131
GBT2104-131
CALIFORNIA
UCSF Benioff Children's Hospital
Oakland, CA 94609
GBT2104-131
GBT2104-131
CALIFORNIA
UC Irvine Medical Center
Orange, CA 92868
GBT2104-131
GBT2104-131
Red blood cells are responsible for carrying oxygen throughout the body. In a person living with sickle cell, some red blood cells change shape and become sickled, or banana shaped. The sickling process begins with hemoglobin, the part of the red blood cell that carries oxygen. When cells sickle, they can break down and there are fewer red blood cells to carry oxygen to all parts of the body. This can cause serious, long-term complications. Sickle cell is always causing damage in the body, even when pain might not be felt.
STATS
It is estimated that:
Americans affected
by SCD
Black or African-American babies are born with SCD
of people living with SCD usually receive their care in an emergency room
SDC is a genetic, hereditary disease
Requires medical diagnosis
Lab tests or imaging always required
Chronic: lifelong
For informational purposes only. Consult your local medical authority for
advice.
Content ources: National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention
SYMPTOMS
Pain areas: in the joints
Pain types: can be sudden
in the
chest,
can include
vaso-occlusive crises (VOCs)
Whole
body: dizziness, fatigue, low oxygen in the body, or malaise
Urinary: inability to
make concentrated or dilute urine or
blood in urine
Also common: abnormal breakdown of red blood cells,
delayed
development, inflamed fingers or toes,
pallor, shortness of breath, or yellow skin and eyes
A vaso-occlusive crisis (VOC) is defined as an acute episode of pain that:
TREATMENT
Management of sickle cell is usually aimed at avoiding pain episodes, like VOCs, relieving symptoms and preventing complications. Treatments might include medications and blood transfusions. Vaccinations and penicillin can be used to help prevent life-threatening infections.
Would you like to know more?
Contact us at THRIVEstudy@gbt.com