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).
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Assess response to therapy on Day 28
Days 3, 5, 7, 14, 21, 28 and 42
No
Pei-Ran Ho, MD
Study Director
Eisai Inc.
United States: Food and Drug Administration
AKR-501-CL-003
NCT00441090
February 2007
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Mount Sinai Medical Center | New York, New York 10029 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Georgetown University | Washington, District of Columbia 20007-2197 |
Bay Area Cancer Research Group, LLC | Concord, California 94520 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
New York Presbyterian Hospital, Weill Medical College of Cornell University | New York, New York 10021 |
Cancer Care Center, Inc. | New Albany, Indiana 47150 |
Comprehensive Bleeding Disorders Center | Peoria, Illinois 61614 |
Pacific Cancer Medical Center, Inc | Anaheim, California 92801 |
Cancer Centers of the Carolina | Greenville, South Carolina 29615 |
Columbus Clinic, PC | Columbus, Georgia 31901 |
Pacific Coast Hematology/Oncology Medical Group Inc. | Fountain Valley, California 92708 |
University of California Irvine Cancer Center | Orange, California 92618 |
Davis, Posteraro and Wasser, MDs, LLP | Manchester, Connecticut 06105 |
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology | Chicago, Illinois 60612 |
Kansas City Cancer Center, LLC | Kansas City, Missouri 64131 |
UMDNJ - Robert Wood Johnson Medical School | News Brunswick, New Jersey 08901 |
Emerywood Oncology and Hematology | High Point, North Carolina 27262 |
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center | Columbus, Ohio 43219 |
UPENN | Philadelphia, Pennsylvania 19104 |
Puget Sound Blood Center | Seattle, Washington 98014 |