A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered t… (NCT01054443) | Clinical Trial Compass
TerminatedPhase 2
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
Stopped: This study was terminated before the planned sample size was enrolled because results indicated that a higher dose was necessary to elicit an efficacy effect.
United States20 participantsStarted 2010-03-18
Plain-language summary
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
Who can participate
Age range18 Years
SexALL
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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
* 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:
* 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 pla…