A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)

• Status: Terminated
• Trial end date: 2010-11-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi

Criteria

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