A Phase 2a, Double-blind, Randomised, Placebo-controlled, Efficacy, and Safety Study of Multiple Doses of VIT-2763 in Subjects With Sickle Cell Disease (ViSionSerenity)

Who is this study for? Patients with sickle cell disease
What treatments are being studied? VIT-2763
Status: Completed
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Male or female subjects with confirmed diagnosis of SCD, including only HbS/S or HbS/βT0 genotype.

• Subjects who had at least 1 and no more than 10 vaso-occlusive crises (VOC) episodes reported 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 months prior to screening Visit V1

• Female subjects of childbearing potential, must have negative pregnancy, must have stopped breastfeeding as of first dose, and must either commit to true abstinence from heterosexual contact or must be willing to use adequate contraceptive precautions.

• Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential

Locations
United States
Alabama
Investigator Site 709
Birmingham
California
Investigator Site 708
Los Angeles
Colorado
Investigator Site 713
Aurora
Florida
Investigator Site 706
Hollywood
Illinois
Investigator Site 703
Chicago
North Carolina
Investigator Site 701
Greenville
South Carolina
Investigator Site 711
Charleston
Wisconsin
Investigator Site 702
Milwaukee
Other Locations
France
Investigator Site 801
Colombes
Investigator Site 802
Lyon
Greece
Investigator site 301
Athens
Investigator Site 305
Athens
Investigator Site 302
Pátrai
Lebanon
Investigator Site 101
Baabda
Investigator Site 102
Beirut
Investigator Site 103
Tripoli
United Kingdom
Investigator Site 606
Liverpool
Investigator Site 601
London
Investigator Site 603
London
Investigator Site 605
London
Investigator Site 608
London
Investigator Site 607
Manchester
Time Frame
Start Date: 2021-11-18
Completion Date: 2024-03-07
Participants
Target number of participants: 25
Treatments
Experimental: Cohort 1
Participants receive VIT-2763 60 mg, twice a day during 8 weeks.
Experimental: Cohort 2
Participants receive VIT-2763 120 mg, twice a day during 8 weeks.
Experimental: Cohort 3
Participants receive VIT-2763 120 mg, three times a day during 8 weeks.
Placebo_comparator: Cohort 4a
Participants receive a placebo, twice a day during 8 weeks.
Placebo_comparator: Cohort 4b
Participants receive a placebo, three times a day during 8 weeks.
Sponsors
Collaborators: Fortrea
Leads: Vifor (International) Inc.

This content was sourced from clinicaltrials.gov

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