A Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered to Adult Subjects With Immune Thrombocytopenia (ITP)
Status: | Terminated |
---|---|
Conditions: | Hematology, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/24/2018 |
Start Date: | January 2010 |
End Date: | December 2010 |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered Once-daily for 42 Days to Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging,
parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics
of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will
be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0
mg or placebo.
parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics
of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will
be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0
mg or placebo.
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, 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
- 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. The dosages of all these medications must be
stable for at least 4 weeks prior to Visit 1 (Day 1)
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 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/mm3
- 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 IgM 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 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)
- Exposure to an investigative medication within the past 30 days
We found this trial at
18
sites
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