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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00441090 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
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). |
Estimated Enrollment: | 65 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Eisai Medical Services | 1-888-422-4743 |
Study Chair: | Akhil Baranwal, MD | MGI Pharma, Inc. - Medical Monitor |
Responsible Party: | Eisai Medical Research Inc. ( Akhil Baranwal, MD ) |
Study ID Numbers: | AKR-501-CL-003 |
Study First Received: | February 27, 2007 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00441090 |
Health Authority: | United States: Food and Drug Administration |
Chronic Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic |
Signs and Symptoms Thrombocytopathy Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic |
Skin Manifestations Immune System Diseases |