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) .
Subcutaneously administered, once a week, for 12 weeks
Eligibility
Sex: ALLMin age: 20 Years
Medical Language ↔ Plain English
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
Outcomes
Primary Outcomes
Weeks With Weekly Platelet Response
Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10\^9/L on a weekly scheduled dose day from week 2 to week 13.
Time frame: 12 weeks (Weeks 2 - 13)
Secondary Outcomes
Increased Platelet Count From Baseline of at Least 20 x 10^9/L
An increase in platelet count of at least 20 x 10\^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.
Time frame: Baseline, 12 weeks (Weeks 2 - 13)
Change From Baseline in Mean of Last 4 Weekly Platelet Counts
Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.
Time frame: 12 weeks (Weeks 2 - 13)
Weeks With Platelet Count Between 50 and 200
Number of weeks with platelet count between 50 x 10\^9/L and 200 x 10\^9/L inclusive during week 2 to week 13.
Time frame: 12 weeks (Weeks 2 - 13)
Rescue Medication(s)
Requirement for rescue medication(s) during treatment by the participant
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NCT00603642 - P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | Crick | Crick