Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

October 31, 2009

Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
DRUG

Blinded (placebo)

"Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)~Duration - 6 months"

DRUG

Open Label (Avatrombopag tablets)

"Dose 10 mg~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)~Duration - 6 months"

DRUG

Blinded (Avatrombopoag tablets)

"Dose: 2.5, 5, 10, or 20 mg~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)~Duration - 6 months"

Trial Locations (12)

10029

Mount Sinai Medical Center, New York

10032

New York Presbyterian Hospital, Weill Medical College of Cornell University, New York

27262

Emerywood Oncology and Hematology, High Point

34655

Florida Cancer Institute, New Port Richey

43219

Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center, Columbus

47150

Cancer Care Center, Inc., New Albany

60612

John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology, Chicago

64131

Kansas City Cancer Center, LLC, Kansas City

65109

Capitol Comprehensive Cancer Care Clinic, Jefferson City

92801

Pacific Cancer Medical Center, Inc, Anaheim

93309

Comprehensive Blood and Cancer Center, Bakersfield

06105

Davis, Posteraro and Wasser, MDs, LLP, Manchester

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00625443 - Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 | Biotech Hunter | Biotech Hunter