A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
The primary objective of this study was to assess the efficacy of 3 dose levels of
 lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
Inclusion Criteria:

 -  A signed and dated written informed consent

 -  Males and females ≥ 18 years of age

 -  All subjects must agree to use barrier contraception

 -  Diagnosis of ITP

 -  Subjects > 60 years must have had a diagnostic bone marrow aspiration

 -  Relapsed persistent or chronic ITP status, with or without prior splenectomy
 (exception: in Hungary only splenectomized subjects will be enrolled), after having
 failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count
 < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or
 other ITP therapies, such as danazol or immunosuppressive drugs

 -  Subjects receiving steroid therapy must be on a stable dose

 -  Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of
 the upper limit of normal (ULN)

 -  Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil,
 azathioprine, or danazol are allowed. The dosages of all these medications must be
 stable for at least 4 weeks prior to Visit 1 (Day 1)

 Exclusion Criteria:

 -  History of clinically important hemorrhagic clotting disorder

 -  Females who are pregnant, lactating, or taking oral contraceptives

 -  History of alcohol/drug abuse or dependence within 1 year

 -  Use of the following drugs or treatment prior to Visit 1 (Day 1):

 -  Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell
 therapy;

 -  Within 8 weeks - rituximab

 -  Within 2 weeks - platelet transfusions or plasmapheresis treatment

 -  Within 4 weeks - use of anti-platelet or anti-coagulant drugs

 -  Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin

 -  History of clinically significant cardiovascular or thromboembolic disease within 26
 weeks prior to Screening

 -  Splenectomy within 4 weeks prior to Screening

 -  Clinically significant laboratory abnormalities

 -  Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP

 -  Absolute neutrophil count < 1000/mm^3

 -  Abnormal peripheral blood smear

 -  Total bilirubin > 1.5 x upper limit of normal

 -  Alanine aminotransferase (ALT) > 1.5 x upper limit of normal

 -  Aspartate aminotransferase (AST) > 1.5 x upper limit of normal

 -  Creatinine > 1.5 x upper limit of normal

 -  Human immunodeficiency virus (HIV) positive

 -  Hepatitis A immunoglobulin M antibody (IgM HAV) positive, hepatitis B surface
 antigen (HbsAg) or hepatitis C antibody (HCV) positive

 -  Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal

 -  Free thyroxine (T4) > 1.5 x upper limit of normal

 -  Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g.,
 eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to
 Screening

 -  Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag,
 romiplostim, E5501 [AKR-501] or LGD-4665)

 -  Exposure to an investigative medication within the past 30 days