Relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy MedDRA version: 12.1 Level: LLT Classification code 10066667 Term: Chronic thrombocytopenia MedDRA version: 12.1 Level: LLT Classification code 10063129 Term: Persisting thrombocytopenia
Conditions
Sponsors
Shionogi USA, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who previously participated in the Phase 2 ITP Study 0913M0621 and who either completed treatment or discontinued treatment due to a platelet count > 400, 000/µL and must also meet all inclusion criteria listed below, including platelet counts 60 years of age must have had a diagnostic bone marrow aspiration within 1 year prior to Screening showing normal or increased numbers of megakaryocytes. 6. Relapsed persistent or chronic ITP status, with or without prior splenectomy, after having failed at least 1 prior ITP therapy (excluding TPO) and have a platelet count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for study participation if he/she meets any of exclusion criteria, or will be discontinued at the discretion of the investigator if he/she develops one or more of the following exclusion criterion during the study. 1. History of inherited or acquired, clinically important hemorrhagic clotting disorder. 2. Females who are pregnant or lactating, or are receiving other hormone/chemical contraceptives that are not exclusively progestin-based. 3. History of alcohol/drug abuse or dependence within 1 year of initial Screening Visit. 4. Use of the following drugs or treatment prior to Day 1: • Within 1 week – Rho(D) immune globulin or intravenous immunoglobulin (IVIG); • 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; 5. History of clinically significant (in the opinion of the investigator) cardiovascular or thromboembolic disease within 26 weeks prior to initial Screening Visit. 6. Splenectomy within 4 weeks prior to Initial Screening Visit. 7. Laboratory abnormalities: • Hemoglobin 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 8. Exposure to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to initial Screening Visit. 9. Subjects unresponsive, defined as the inability to attain adequate platelet count despite optimal dosing of previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665), based on investigator’s discretion. 10. Exposure to an investigative medication, other than S-888711, within the past 4 weeks prior to the initial Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of S-888711;Secondary Objective: - Assess dose requirements for long-term platelet response - Assess durability of platelet response - Evaluate bleeding events by World Health Organization (WHO) bleeding criteria ;Primary end point(s): • Safety will be assessed by monitoring clinical laboratory evaluations (including hematology, blood biochemistry, urinalysis, blood smears), vital signs, physical examinations, electrocardiograms, and World Health Organization (WHO) bleeding assessments. • Treatment-emergent AEs and serious adverse events (SAEs) will be collected and tabulated. • Frequency distribution of S-888711 doses subjects receive over time • Duration of response from baseline to various timepoints, as the proportion of the cumulative time spent with a platelet count of = 50,000/µL; and • Incidence and severity of bleeding associated with ITP. • The proportion of subjects who achieve a platelet count of = 50,000/µL at various time intervals; • Change from baseline at various time intervals in platelet counts. | — |
Countries
France, Germany, Hungary, Italy, United Kingdom
Outcome results
None listed