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-132, 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.
Dosage: 1 treatment
Trial Population: Patients
over 16yr; no
gender requirement
HCP-led
entry: Participant must have had 2-10 crises over the past 12mo AND been taken to a
medical
facility (hospital,
emergency department, urgent care center, outpatient clinic, or infusion center) or results in a
remote contact with a
healthcare provider
Participants that complete the study through Week 48 will
be provided the
opportunity to enroll in.
an open-label extension (OLE) study, THRIVE*.
*Please contact THRIVEstudy@gbt.com if you have any questions.
Find out if your patient(s) are eligible to participate in the THRIVE-132 study.
Eligibility Requirements
Study Duration:
October 2021 to October 2023
Total Duration per
Participant:
48 weeks
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MICHIGAN
University Hospital
Ann Arbor, MI 48109
GBT2104-132
GBT2104-132
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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
sources: 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 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