An observational study in Healthy and Sickle Cell Disease, sponsored by Bioverativ Therapeutics Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Bioverativ Therapeutics Inc. · Observational
The purpose of the study is to determine whether imaging techniques, such as magnetic resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in different organ systems of participants with sickle cell disease (SCD). Differences in blood flow and oxygen levels detected by these techniques will be evaluated to determine their utility as biomarkers of clinical disease pathophysiology.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Bioverativ Therapeutics Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with mild to severe VOC
Key Inclusion Criteria:
Be in stable clinical condition, as determined by the Investigator.
Subjects enrolled in Part B must also meet the following eligibility criterion at Screening:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Cohort 1- Participants with severe SCD (4-10 VOC/year) Cohort 2- Participants with milder SCD (\<4-10 VOC/year) Cohort 3- Healthy volunteers Part A and B can occur in parallel
Adults with SCD receiving chronic red blood cell exchange transfusion Part A and B can occur in parallel
Blood flow in the brain of adults with severe SCD (4-10 vaso-occlusive crises [VOC]/ year) compared to healthy adults without SCD as assessed by MRI-ASL (arterial spin labeling)
Time frame: Up to day 18 post screening visit
Kidney blood flow rates as assessed by MRI-SWI (susceptibility-weighted imaging)
Time frame: Up to day 21 post screening visit
Skeletal muscle blood flow rates as assessed by NIRS
Time frame: Up to day 21 post screening visit
Skin blood flow rates as assessed by LSCI
Time frame: Up to day 21 post screening visit
Retinal blood flow rates as assessed by OI
Time frame: Up to day 21 post screening visit
Total oxygen levels in the brain as assessed by MRI-ASL
Time frame: Up to day 21 post screening visit
Total oxygen levels in the kidney as assessed by MRI-SWI
Time frame: Up to day 21 post screening visit
Total oxygen levels in the muscle as assessed by NIRS
Time frame: Up to day 21 post screening visit
Total oxygen levels in the skin as assessed by LSCI
Time frame: Up to day 21 post screening visit
Total oxygen levels in the retina as assessed by OI
Time frame: Up to day 21 post screening visit
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bioverativ Therapeutics Inc.