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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID

NCT01054443

Run by

Shionogi

People needed

20

Starts

2010-03-18

Expected to finish

2010-11-24

Last updated by the study team

2021-03-18

Who can join

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

You may qualify 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 qualify 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 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)

Where it is running

• Investigator — Anaheim, California, United States
• Investigator — Los Angeles, California, United States
• Investigator — Washington D.C., District of Columbia, United States
• Investigator — Boynton Beach, Florida, United States
• Investigator — Jacksonville, Florida, United States
• Investigator — Atlanta, Georgia, United States
• Investigator — Riverdale, Georgia, United States
• Investigator — Metairie, Louisiana, United States
• Investigator — Bethesda, Maryland, United States
• Investigator — Boston, Massachusetts, United States
• Investigator — Jefferson City, Missouri, United States
• Investigator — Kansas City, Missouri, United States
• Investigator — New Brunswick, New Jersey, United States
• Investigator — New York, New York, United States
• Investigator — New York, New York, United States
• Investigator — Cleveland, Ohio, United States
• Investigator — San Antonio, Texas, United States
• Investigator — Salt Lake City, Utah, United States
• Investigator — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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