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

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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.


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
New Brunswick, New Jersey 08901
2410
mi
from 91732
New Brunswick, NJ
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16
mi
from 91732
Anaheim, CA
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1919
mi
from 91732
Atlanta, GA
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2277
mi
from 91732
Bethesda, MD
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2578
mi
from 91732
Boston, MA
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2309
mi
from 91732
Boynton Beach, FL
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2032
mi
from 91732
Cleveland, OH
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2127
mi
from 91732
Jacksonville, FL
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1462
mi
from 91732
Jefferson City, MO
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1341
mi
from 91732
Kansas City, MO
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13
mi
from 91732
Los Angeles, CA
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1648
mi
from 91732
Metairie, LA
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2435
mi
from 91732
New York, NY
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1920
mi
from 91732
Riverdale, GA
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570
mi
from 91732
Salt Lake City, UT
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1188
mi
from 91732
San Antonio, TX
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964
mi
from 91732
Seattle, WA
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2281
mi
from 91732
Washington,
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