Clinical Trial
Study Details
Participants receive 2 capsules of VIT-2763 30 mg in the morning and in the evening, for 8 weeks.
Capsules are to be taken orally.
Participants receive 2 capsules of VIT-2763 60 mg in the morning, in the afternoon and in the evening for 8 weeks.
Capsules are to be taken orally.
Participants receive 2 capsules of VIT-2763 60 mg in the morning and in the evening, for 8 weeks.
Capsules are to be taken orally.
Participants receive 2 capsules of placebo in the morning and in the evening, for 8 weeks.
Capsules are to be taken orally.
Participants receive 2 capsules of Placebo in the morning, in the afternoon and in the evening, for 8 weeks.
Capsules are to be taken orally.
The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.
Study Overview
At randomization/baseline, participants are randomized into 3 VIT-2763 dose groups to receive either 60 mg twice daily (BID) (Cohort 1), or 120 mg BID (Cohort 2), or 120 mg 3 times daily (TID) (Cohort 3) and 2 placebo groups (BID, Cohort 4a or TID, Cohort 4b).
The expected duration of patient participation is a maximum of 16 weeks, including a non-treatment screening period of up to 4 weeks, and 8-week treatment period, and a 4-week safety follow-up period.
Contacts and Locations
Investigator Site 709
Birmingham, Alabama 35233-2110
United States
Investigator Site 708
Los Angeles, California 90027
United States
Investigator Site 713
Aurora, Colorado 80045
United States
Investigator Site 706
Hollywood, Florida 33023
United States
Investigator Site 703
Chicago, Illinois 60612
United States
Investigator Site 701
Greenville, North Carolina 27834
United States
Investigator Site 711
Charleston, South Carolina 29425
United States
Investigator Site 702
Milwaukee, Wisconsin 53226
United States
Investigator Site 801
92700 Colombes
France
Investigator Site 802
690003 Lyon
France
Investigator Site 305
11527 Athens
Greece
Investigator site 301
GR-11527 Athens
Greece
Investigator Site 302
Pátrai
Greece
Investigator Site 101
Baabda
Lebanon
Investigator Site 102
Beirut
Lebanon
Investigator Site 103
Tripoli
Lebanon
Investigator Site 606
Liverpool
L9 7AL
United Kingdom
Investigator Site 603
London
SE59RS
United Kingdom
Investigator Site 608
London
W12 0HS
United Kingdom
Investigator Site 601
London
United Kingdom
Investigator Site 605
London
United Kingdom
Investigator Site 607
Manchester
M13 9WL
United Kingdom