Status:
COMPLETED
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Eisai Inc.
Conditions:
Chronic Idiopathic Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Idiopathic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Thr...
Detailed Description
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- IgM HAV positive, Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV) positive.
- History of, or current alcohol or drug abuse likely to interfere with ability to comply with protocol.
- requirements or give informed consent, as determined by the Investigator.
- History of, or current psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent, as determined by the Investigator.
- Currently taking any of the following medications: Rituximab, Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00441090
Start Date
February 1 2007
End Date
June 1 2009
Last Update
March 7 2018
Active Locations (25)
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1
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
3
Bay Area Cancer Research Group, LLC
Concord, California, United States
4
Pacific Coast Hematology/Oncology Medical Group Inc.
Fountain Valley, California, United States, 92708