P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Placebo; AMG 531
Intervention description: Subcutaneously administered, once a week, for 12 weeks; Subcutaneously administered, once a week, for 12 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: AMG 531; Idiopathic Thrombocytopenic Purpura; ITP; Thrombocytopenia; Japan; Placebo controlled; Phase 3

Summary:

      The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with
      placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic
      purpura (ITP) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed
             by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of
             Health, Labour and Welfare [MHLW] (revised in 1990) at least 6 months before the first
             screening visit

          -  The mean of the 3 scheduled platelet counts taken at the scheduled visits during the
             screening period must be ≤ 30 x 10^9/L, with no individual count > 35 x 10^9/L

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Subjects must be ≥ 20 years of age at the time of obtaining the informed consent

          -  Have received at least 1 prior treatment for ITP

          -  If known Helicobacter pylori positive, having completed one course of Helicobacter
             pylori eradication therapy at least 12 weeks before the first screening visit

          -  A hemoglobin value taken at scheduled visit during the screening period must be ≥ 10
             g/dL

          -  A serum creatinine concentration taken at scheduled visit during the screening period
             must be ≤ 2 mg/dL

          -  Adequate liver function, as evidenced by a total bilirubin taken at scheduled visit
             during the screening period ≤ 1.5 times of the upper limit of the normal range (except
             for patients with a confirmed diagnosis of Gilbert's Disease) or an alanine
             aminotransferase and aspartate aminotransferase taken at the screening visit ≤ 3 times
             of the upper limit of the normal range

        Exclusion Criteria:

          -  Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings
             other than those typical of ITP.

          -  Any active malignancy. If prior history of cancer other than basal cell carcinoma or
             cervical carcinoma in situ, no treatment or active disease within 5 years before the
             first screening visit.

          -  Documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or
             myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis,
             pulmonary embolism) and receiving anticoagulation therapy at the first screening
             visit.

          -  Documented diagnosis of anti phospholipid antibody syndrome

          -  Currently receiving any treatment for ITP except oral corticosteroids, azathioprine
             and/or danazol administered at a constant dose and schedule from at least 4 weeks
             prior to the first screening visit

          -  Received intravenous immunoglobulin, anti D immunoglobulin, or any drug administered
             to increase platelet counts (eg, immunosuppressants except azathioprine) within 2
             weeks before the first screening visit

          -  Have had a splenectomy for any reason within 12 weeks before the first screening visit

          -  Past or present participation in any study evaluating pegacaristim (polyethylene
             glycol-conjugated recombinant human megakaryocyte growth and development factor,
             KRN9000), Eltrombopag (SB 497115), recombinant human thrombopoietin, AMG 531, or other
             Mpl stimulation product

          -  Received hematopoietic growth factors (eg, granulocyte colony stimulating factor,
             macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason
             within 4 weeks before the first screening visit

          -  Received any anti malignancy agents (eg, cyclophosphamide, 6 mercaptopurine,
             vincristine, vinblastine, Interferon alfa) for any reason within 8 weeks before the
             first screening visit

          -  Received any monoclonal antibody drugs (eg, rituximab) for any reason within 14 weeks
             before the first screening visit

          -  Less than 4 weeks since receipt of any therapeutic drug or device that is not MHLW
             approved for any indication before the first screening visit

          -  Pregnant or breast feeding

          -  Subjects of reproductive potential who are not using adequate contraceptive
             precautions, in the judgment of the investigator

          -  Known severe drug hypersensitivity

          -  Concerns for subject's compliance with the protocol