Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic

In brief

The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).

Key facts

Study ID

NCT00441090

Run by

Eisai Inc.

People needed

64

Starts

2007-02-01

Expected to finish

2009-06-01

Last updated by the study team

2018-03-07

Who can join

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

You may qualify if…

• Men and women ≥ 18 years of age.
• Confirmed diagnosis of ITP according to American Society of Hematology (ASH) Guidelines ≥ 3 months prior to Day 1.
• If ≥ 60 years old, must have had either a bone marrow biopsy consistent with ITP within past 3 years or a good response (platelet count > 100,000/mm\^3) to a previous ITP treatment.
• Are refractory or relapsed after at least one prior ITP therapy (patients who are refractory and failed to achieve a platelet count ≥ 50,000/mm\^3 despite steroids or ≥ 30,000/mm\^3 to other prior ITP therapies, such as splenectomy, danazol, or immunosuppressive drugs. For patients who are relapsed, the platelet counts must be below 50,000/mm\^3 if using steroids or 30,000/mm\^3 if not prescribed steroids.)
• Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose (same milligram amount ± 10%) for ≥ 2 weeks prior to Screening Visit A 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.
• Patients receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine or danazol may also be enrolled. The dosages of all these medications must be stable for at least 3 months prior to AKR-501 administration.
• Platelet count:
• Patients not receiving steroids (no steroid treatment for > 2 weeks prior to the Screening Visit A): platelets < 30,000/mm\^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B)
• Patients receiving steroids: platelets < 50,000/mm\^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B).
• Women of child-bearing potential must have a negative pregnancy test at Screening Visit A and Screening Visit B. (Childbearing potential is defined as any woman who has not been surgically sterilized and is premenopausal or peri-menopausal i.e., any menstrual flow within 12 months of Screening Visit A).
• Women of child-bearing potential and all men 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 before any study-related procedure.

You may not qualify if…

• Women who are pregnant and/or lactating.
• Splenectomy procedure performed 4 weeks prior to AKR-501 administration.
• Use of the following drugs or treatments prior to Day 1:
• Within 3 months - Rituximab;
• Within 2 weeks - Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
• Participation in a clinical trial involving any investigational agent within 4 weeks of Day 1.
• Exposure to eltrombopag or AMG -531.
• Significant medical conditions or diseases as determined by the Investigator (e.g., clinically active systemic lupus erythematosus; known or suspected HIV infection; acute hepatitis or clinically active chronic hepatitis; lymphoproliferative disease; congestive heart failure).
• History of cardiovascular disease (e.g., angina, unstable angina, myocardial infraction, coronary artery stent placement, angioplasty, coronary artery bypass grafting).
• History of thromboembolic disease (e.g., transient ischemic attack [TIA], stroke [CVA], pulmonary embolism [PE]).
• History of deep venous thrombosis (DVT).
• History of lupus anticoagulant or anticardiolipin antibody syndrome or positive anti b2 glycoprotein antibody.
• History of any medical condition where systemic anticoagulation was required for more than 6 months.
• Laboratory abnormalities:
• Hemoglobin < 12.5 g/dL for men and < 11.5 g/dL for women. If anemia is clearly related to ITP, for example excessive blood loss, then that patient may be enrolled without the need for a waiver after discussion with the Sponsor's medical monitor
• White blood cell count (WBC) < lower limit of normal
• Absolute neutrophil count (ANC) < 1000/mm\^3
• Prothrombin time (PT) > 1.25 x upper limit of normal
• Partial thromboplastin time (PTT) > 1.25 x upper limit of normal
• Total bilirubin > 3 x upper normal limit
• Alanine transaminase (ALT) > 3 x upper normal limit
• Aspartate transaminase (AST) > 3 x upper normal limit
• Creatinine > 1.5x upper normal limit
• Blood urea nitrogen (BUN) > 1.5 x upper normal limit
• HIV positive

Where it is running

• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Bay Area Cancer Research Group, LLC — Concord, California, United States
• Pacific Coast Hematology/Oncology Medical Group Inc. — Fountain Valley, California, United States
• University of California Irvine Cancer Center — Orange, California, United States
• Davis, Posteraro and Wasser, MDs, LLP — Manchester, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• Columbus Clinic, PC — Columbus, Georgia, United States
• John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology — Chicago, Illinois, United States
• Comprehensive Bleeding Disorders Center — Peoria, Illinois, United States
• Cancer Care Center, Inc. — New Albany, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Capitol Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• Kansas City Cancer Center, LLC — Kansas City, Missouri, United States
• UMDNJ - Robert Wood Johnson Medical School — New Brunswick, New Jersey, 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
• UPENN — Philadelphia, Pennsylvania, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• Cancer Centers of the Carolina — Greenville, South Carolina, United States
• Puget Sound Blood Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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