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

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Thrombocytopenic Purpura

In brief

The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).

Key facts

Study ID

NCT00625443

Run by

Eisai Inc.

People needed

53

Starts

2007-05-01

Expected to finish

2009-10-01

Last updated by the study team

2018-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who completed 28 days of study treatment in Protocol 501-CL-003.
• No significant safety or tolerability concerns from the patient's participation of Protocol 501-CL-003 as determined by the Investigator.
• Received medical monitor approval for enrollment into this study.
• Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose and the Investigator does not foresee the need to change the steroid dose during study participation. Patients should remain on this stable corticosteroid dose during study participation.
• Women of child-bearing potential must have a negative serum pregnancy test at the Day 28 assessment in Protocol 501-CL-003. (Childbearing potential is defined as any woman who has not been surgically sterilized and is pre-menopausal or peri-menopausal i.e., any menstrual flow within 12 months of Screening Visit A for Protocol 501-CL-003).
• Women of child-bearing potential 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).
• Willing and able to provide written informed consent.

You may not qualify if…

• Women who are pregnant and/or lactating.
• Use of the following drugs or treatments:
• Rituximab
• Azathioprine, Cyclosporine A, or other immunosuppressant therapy
• Aspirin, Aspirin-containing compounds, Salicylates,Anticoagulants, Non-steroidal anti-inflammatory drugs(NSAIDs)(including Cyclooxygenase-2 [COX-2] specific NSAIDs), clopidogrel; ticlopidine; and any drugs that affect platelet function.
• Danazol
• Rh0(D) immune globulin (WinRho®) or intravenous immunoglobulin (IVIG).
• Inability to comply with protocol requirements or give informed consent, as determined by the Investigator.
• For more information regarding inclusion/exclusion criteria, please see record for AKR 501-CL-003 Protocol.

Where it is running

• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Davis, Posteraro and Wasser, MDs, LLP — Manchester, Connecticut, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology — Chicago, Illinois, United States
• Cancer Care Center, Inc. — New Albany, Indiana, United States
• Capitol Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• Kansas City Cancer Center, LLC — Kansas City, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• New York Presbyterian Hospital, Weill Medical College of Cornell University — New York, New York, United States
• Emerywood Oncology and Hematology — High Point, North Carolina, United States
• Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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