An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)

• Status: Terminated
• Trial end date: 2011-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.

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

Details

• Lead Sponsor: Shionogi

Criteria

Inclusion Criteria:

• Subjects who previously participated in Study 0913M0621 (NCT01054443) and who completed treatment or discontinued treatment due to a platelet count > 400,000/μL and continued to meet all inclusion criteria of the previous study, listed below, including platelet counts < 50,000/μL were eligible for study participation. For the purpose of this study, initial screening visit and all prestudy time period refer to Study 0913M0621.

• 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

• Subjects receiving steroid therapy must be on a stable dose for at least 2 weeks prior to Screening

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

• Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed

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

• Within 2 weeks - plasmaphoresis treatment;

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

• Within 8 weeks - rituximab;

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

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

• Splenectomy within 4 weeks prior to Initial Screening

• Clinically significant laboratory abnormalities

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

• Absolute neutrophil count < 1000/mm3

• Abnormal peripheral blood smear with evidence of fibrosis confirmed by bonemarrow biopsy

• 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 positive

• Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive

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

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

• Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit