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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 |
| 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). |
| Enrollment: | 64 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | July 2009 |
| Primary Completion Date: | January 2009 (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
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Drug: AKR-501 Tablets
AKR-501 Tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
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Placebo tablet: Placebo Comparator
2.5, 5, 10, or 20 mg tablets 1 tablet taken orally once daily for 28 days
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Drug: Placebo
Placebo Tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Platelet count:
Women of child-bearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used:
condoms (male or female) with a spermicidal agent, diaphragm, or cervical cap with a spermicidal agent, IUD, hormonal contraception, abstinence).
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
Show 25 Study Locations| Study Director: | Pei-Ran Ho, MD | Eisai Medical Research Inc. |
More Information
| Responsible Party: | Eisai Medical Research Inc. ( Pei-Ran Ho, MD ) |
| Study ID Numbers: | AKR-501-CL-003 |
| Study First Received: | February 27, 2007 |
| Last Updated: | April 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00441090 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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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 |
|
Purpura Signs and Symptoms Skin Manifestations Autoimmune Diseases Hemorrhagic Disorders Thrombocytopenia |
Immune System Diseases Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic |