An Open-label Safety Study of S-888711
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hematology |
Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/25/2018 |
Start Date: | March 2010 |
End Date: | September 2011 |
An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy
This is a Phase 2, multicenter, open-label, extension study to evaluate the safety of
S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate
in this study must have completed the Phase 2 double-blind, randomized, placebo controlled
study.
S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate
in this study must have completed the Phase 2 double-blind, randomized, placebo controlled
study.
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
- Subjects receiving steroid therapy must be on a stable dose
- PT and APTT within 20% of the upper limit of normal
- 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 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
We found this trial at
18
sites
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