Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04056195
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2019-08-12
Brief Title:
Study of Oral SKI-O-703 SYK Inhibitor in Patients With Persistent and Chronic Immune Thrombocytopenia ITP
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 SYK Inhibitor in Patients With Persistent and Chronic Immune Thrombocytopenia ITP
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study in patients with persistent and chronic Immune Thrombocytopenia ITP who have failed to respond or relapsed after prior therapy with a platelet count 30000µL Patient will be randomly assigned in 2 groups with two dose levels of SKI-O-703 200mg BID 400 mg BID and placebo administered orally twice a day
Detailed Description:
This study will evaluate the efficacy safety tolerabilitypharmacokinetics PK and pharmacodynamics PD of select 200 mg BID and 400 mg BID doses of SKI-O-703 in persistent and chronic ITP patients who have failed to respond or relapsed after prior therapy with a platelet count 30000µL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment
subjects will participate in 3 treatment groups 24 subjects in each of the active treatment groups and 12 subjects in the placebo group The total study duration will be 20 weeks per subject which consists of up to 4 weeks of screening period 12 weeks of treatment period and 4 weeks of follow-up period
subjects will participate in 3 treatment groups 24 subjects in each of the active treatment groups and 12 subjects in the placebo group The total study duration will be 20 weeks per subject which consists of up to 4 weeks of screening period 12 weeks of treatment period and 4 weeks of follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None