Study to Assess Efficacy and Safety of VIT-2763 in Subjects With Sickle Cell Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
At randomisation/baseline (Part A), subjects are randomised in a 1:1:1:1:1 ratio into 4 VIT 2763 dose groups to receive either 30 mg (Cohorts 1a and 1b) or 60 mg VIT-2763 (Cohorts 2a and 2b) and 1 placebo group (Cohort 3). During Part B, subjects in Cohort 1a (VIT-2763 30 mg) and Cohort 2a (VIT-2763...
At randomisation/baseline (Part A), subjects are randomised in a 1:1:1:1:1 ratio into 4 VIT 2763 dose groups to receive either 30 mg (Cohorts 1a and 1b) or 60 mg VIT-2763 (Cohorts 2a and 2b) and 1 placebo group (Cohort 3). During Part B, subjects in Cohort 1a (VIT-2763 30 mg) and Cohort 2a (VIT-2763 60 mg) remain on the same VIT-2763 dose as in Part A; whereas, subjects in Cohort 1b and Cohort 2b continue with an increased dose of VIT-2763, 60 mg and 120 mg, respectively. Subjects randomised to placebo during Part A (Cohort 3) continue unchanged during Part B. The primary objective of this study is to explore the effect of VIT-2763 on markers of haemolysis. The main exploratory objective is to explore the safety and tolerability of VIT-2763.
Tracking Information
- NCT #
- NCT04817670
- Collaborators
- Not Provided
- Investigators
- Study Director: Julian V. Platon, MD, PhD Vifor Pharma Management Ltd.
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