NCT01054443TerminatedPhase 2
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
Shionogi1 site in 1 country20 target enrollmentStarted: March 18, 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With a Response
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
Arms & Interventions
Placebo
Placebo Comparator
Participants received placebo tablets orally once a day for 42 days.
Intervention: Placebo (Drug)
Lusutrombopag 0.5 mg
Experimental
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
Intervention: Lusutrombopag (Drug)
Lusutrombopag 0.75 mg
Experimental
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
Intervention: Lusutrombopag (Drug)
Lusutrombopag 1.0 mg
Experimental
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
Intervention: Lusutrombopag (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With a Response
Time Frame: Week 6
Responders were participants with one of the following: 1. achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or 2. prematurely withdrawn due to a platelet count \> 400,000 cells/µL prior to Day 42. Participants were counted as non-responders if any of the following conditions held: * The above conditions were not satisfied; * They received rescue medications; * They satisfied the above conditions after receiving restricted medications during the treatment period; * They had achieved a platelet count of ≥ 50,000 cells/µL before Week 6 but not after Week 6; or * They withdrew for any reason other than a platelet count \> 400,000 cells/µL.
Secondary Outcomes
- Number of Participants Who Received Rescue Medication During the Treatment Period(6 weeks)
- Percentage of Participants Who Achieved a Platelet Count of ≥ 30,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing(Week 6)
- Percentage of Participants Who Achieved a Platelet Count of ≥ 50,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing(Week 6)
- Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,(6 weeks)
- Change From Baseline in Platelet Count at Week 6(Baseline and Week 6)
- Duration of Response(6 weeks)
- Number of Participants With Adverse Events (AEs)(6 weeks)
- Lusutrombopag Plasma Concentration(Days 8, 22, and 36, after dosing)
- Plasma Concentration of Metabolite S-888711 Deshexyl(Days 8, 22, and 36, after dosing)
Investigators
Study Sites (1)
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