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
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.
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.
Pei-Ran Ho, MD
United States: Food and Drug Administration
|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|
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