A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
NCT ID: NCT01054443
Last Updated: 2021-03-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2010-03-18
2010-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo tablets orally once a day for 42 days.
Placebo
Tablet
Lusutrombopag 0.5 mg
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
Lusutrombopag
Tablet
Lusutrombopag 0.75 mg
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
Lusutrombopag
Tablet
Lusutrombopag 1.0 mg
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
Lusutrombopag
Tablet
Interventions
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Placebo
Tablet
Lusutrombopag
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN)
* 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
* 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/mm\^3
* 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 immunoglobulin M 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 thrombopoietin (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
18 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Investigator
Anaheim, California, United States
Investigator
Los Angeles, California, United States
Investigator
Washington D.C., District of Columbia, United States
Investigator
Boynton Beach, Florida, United States
Investigator
Jacksonville, Florida, United States
Investigator
Atlanta, Georgia, United States
Investigator
Riverdale, Georgia, United States
Investigator
Metairie, Louisiana, United States
Investigator
Bethesda, Maryland, United States
Investigator
Boston, Massachusetts, United States
Investigator
Jefferson City, Missouri, United States
Investigator
Kansas City, Missouri, United States
Investigator
New Brunswick, New Jersey, United States
Investigator
New York, New York, United States
Investigator
New York, New York, United States
Investigator
Cleveland, Ohio, United States
Investigator
San Antonio, Texas, United States
Investigator
Salt Lake City, Utah, United States
Investigator
Seattle, Washington, United States
Countries
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Other Identifiers
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0913M0621
Identifier Type: -
Identifier Source: org_study_id
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