Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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 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
