A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
Patients eligible to enroll into this rollover protocol will begin study treatment within
2-5 days of their Day 28 study termination visit in Protocol 501-CL-003. Patients who met
the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the
same study treatment to which they were assigned in the previous protocol in a
double-blinded manner, these being one of the following 5 treatments:
- AKR-501 2.5 mg daily
- AKR-501 5 mg daily
- AKR-501 10 mg daily
- AKR-501 20 mg daily
- Placebo
Patients who did not meet the primary efficacy response criterion in Protocol 501-CL-003 who
otherwise meet the eligibility criteria for this rollover protocol will be offered open
label AKR-501 10 mg daily.
This is a parallel group, rollover study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
To assess the safety and tolerability of AKR-501 administered for an additional 6 months in patients with chronic ITP who completed 28 days of treatment in Protocol 501-CL-003.
Day 1 thru Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.
No
Pei-Ran Ho, MD
Study Director
Eisai Inc.
United States: Food and Drug Administration
AKR-501-CL-004
NCT00625443
May 2007
February 2010
Name | Location |
---|---|
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Mount Sinai Medical Center | New York, New York 10029 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
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 |
Pacific Cancer Medical Center, Inc | Anaheim, California 92801 |
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 |
Emerywood Oncology and Hematology | High Point, North Carolina 27262 |
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center | Columbus, Ohio 43219 |