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| Sponsored by: |
Eisai Medical Research Inc. |
|---|---|
| Information provided by: | Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00441090 |
Purpose
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 tablets, as compared to placebo, in the treatment of patients with chronic Idiopathic Thrombocytopenic Purpura (ITP).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic |
Drug: Placebo Drug: AKR-501 Tablets |
Phase II |
| Arms | Assigned Interventions |
|---|---|
|
AKR-501 Tablets: Experimental
2.5, 5, 10 or 20 mg tablets 1 tablet taken orally once daily for 28 days |
Drug: AKR-501 Tablets
AKR-501 Tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days
|
|
Placebo tablet: Placebo Comparator
2.5, 5, 10, or 20 mg tablets 1 tablet taken orally once daily for 28 days |
Drug: Placebo
Placebo Tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days
|
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The PK and PK/PD relationship of AKR-501 will also be studied. Approximately 65 eligible patients will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either AKR-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) AKR-501 pharmacokinetics 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 28±1, patients who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 based on this visit.
Eligibility
Inclusion Criteria:
Platelet count:
Exclusion Criteria:
Use of the following drugs or treatments prior to Day 1:
Laboratory abnormalities:
History of, or current alcohol or drug abuse likely to interfere with ability to comply with protocol.
requirements or give informed consent, as determined by the Investigator.
Contacts and Locations| Contact: Eisai Medical Services | 1-888-422-4743 |
Show 25 Study Locations| Study Chair: | Akhil Baranwal, MD | MGI Pharma, Inc. - Medical Monitor |
More Information