Phase
Condition
Sickle Cell Disease
Red Blood Cell Disorders
Treatment
Placebo BID
Placebo TID
VIT-2763 360 mg
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects with confirmed diagnosis of SCD, including only HbS/S orHbS/βT0 genotype.
Subjects who had at least 1 and no more than 10 vaso-occlusive crises (VOC) episodesreported within 12 months prior to screening.
Body weight ≥40 kg and ≤120 kg at screening and baseline.
Subjects on concomitant hydroxyurea must be on a stable dose (mg/kg) for ≥3 monthsprior to screening Visit V1
Female subjects of childbearing potential, must have negative pregnancy, must havestopped breastfeeding as of first dose, and must either commit to true abstinencefrom heterosexual contact or must be willing to use adequate contraceptiveprecautions.
Male subjects must practice true abstinence or agree to use a condom during sexualcontact with a pregnant female or a female of childbearing potential
Exclusion
Exclusion Criteria:
Hb level <6.0 g/dl or >10.4 g/dl for female participants and >11.0 g/dl for maleparticipants, at screening Visit V1
Having received red blood cell (RBC) transfusion therapy within 4 weeks prior toscreening, or ongoing or planned RBC transfusion therapy during the course of thestudy
Low levels of Ferritin or transferrin saturation or total iron-binding capacity atscreening
Subjects being hospitalized for SCD-related events within 14 days before thescreening visit
Chronic liver disease or history of liver cirrhosis, and/or high levels of alanineaminotransferase or aspartate aminotransferase at baseline
Low estimated glomerular filtration rate, and/or significant high urinaryalbumin/creatinine ratio at screening or on chronic dialysis.
Newly diagnosed folate deficiency anemia, which is considered clinically relevant bythe Investigator at screening
Any history or clinically important finding of cardiac or pulmonary disorders
Family history of long-QT syndrome or sudden death without a preceding diagnosis ofa condition that could be causative of sudden death
Clinically significant bacterial, fungal, parasitic, or viral infection whichrequires therapy. Note: A subject meeting this criterion should delay screeningand/or enrolment for a minimum of 2 weeks, or if excluded can be re-screened at alater time point.
Concomitant use of certain hormonal contraceptives as defined in the study protocol,are not allowed within 4 weeks prior to screening and until 1 week after the lastadministration of the study drug and the use of progesterone-only hormonalcontraception as the sole measure to prevent pregnancy.
Pregnant or females currently breastfeeding.
History or known concomitant solid tumours and/or haematological malignancies unlessresolved in the ≥2 past years, except for basal or squamous cell carcinoma of theskin, carcinoma in situ of the cervix or breast, incidental histologic finding ofprostate cancer
Unable to take and absorb oral medications
Acute peptic stomach or duodenal ulcer in the previous 6 months before screeningand/or healed after 3 months of treatment.
Uncontrolled hemorrhages
Study Design
Study Description
Connect with a study center
Investigator Site 801
Colombes, 92700
FranceSite Not Available
Investigator Site 802
Lyon, 690003
FranceSite Not Available
Investigator Site 305
Athens, 11527
GreeceSite Not Available
Investigator site 301
Athens, GR-11527
GreeceSite Not Available
Investigator Site 302
Patra,
GreeceSite Not Available
Investigator Site 101
Baabda,
LebanonSite Not Available
Investigator Site 102
Beirut,
LebanonSite Not Available
Investigator Site 103
Tripoli,
LebanonSite Not Available
Investigator Site 606
Liverpool, L9 7AL
United KingdomSite Not Available
Investigator Site 601
London,
United KingdomSite Not Available
Investigator Site 603
London, SE59RS
United KingdomSite Not Available
Investigator Site 605
London,
United KingdomSite Not Available
Investigator Site 608
London, W12 0HS
United KingdomSite Not Available
Investigator Site 607
Manchester, M13 9WL
United KingdomSite Not Available
Investigator Site 709
Birmingham, Alabama 35233-2110
United StatesSite Not Available
Investigator Site 708
Los Angeles, California 90027
United StatesSite Not Available
Investigator Site 713
Aurora, Colorado 80045
United StatesSite Not Available
Investigator Site 714
Washington, District of Columbia 20060
United StatesSite Not Available
Investigator Site 706
Hollywood, Florida 33023
United StatesSite Not Available
Investigator Site 703
Chicago, Illinois 60612
United StatesSite Not Available
Investigator Site 701
Greenville, North Carolina 27834
United StatesSite Not Available
Investigator Site 711
Charleston, South Carolina 29425
United StatesSite Not Available
Investigator Site 702
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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