Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441090
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2007-02-27
Brief Title:
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura ITP
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase 2 Double-Blind Randomized Dose-Ranging Placebo-Controlled Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura ITP
Status:
COMPLETED
Status Verified Date:
2018-02
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:
The purpose of this study is to determine the efficacy safety and tolerability of AKR-501 avatrombopag tablets as compared to placebo in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura ITP
Detailed Description:
This is a Phase 2 multi-center double-blind randomized placebo-controlled dose-ranging parallel-group study The pharmacokinetic PK and pharmacokineticpharmacodynamic PKPD relationship of avatrombopag will also be studied Approximately 65 eligible participants will be randomized in a 33331 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 25 5 10 or 20 mg or placebo for 28 days respectively Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants All study participants will be evaluated weekly Days 3 5 7 14 21 and 28 for safety efficacy and Days 7 14 21 and 28 avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose Day 42
At the completion of Visit Day 281 participants who complete 281 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 NCT00625443 based on this visit
At the completion of Visit Day 281 participants who complete 281 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 NCT00625443 based on this visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None