Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Brief Summary: This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.


Options:
A: Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject has a diagnosis of Idiopathic Thrombocytopenia Purpura (ITP) according to the American Society of Hematology (ASH) guidelines
* If subject is \> 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP
* Subject has received at least 1 prior therapy for ITP
* Subject has a platelet count \< 50,000 or their platelet count falls to \< 50,000 during or after a clinically-indicated taper or discontinuation of current ITP therapy
* Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

* Subject has had a splenectomy for any reason
* Subject has an active malignancy
* Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years
* Subject has a known history of bone marrow stem cell disorder
* Subject has participated in any study evaluating polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein
* Subject is receiving other investigational agents or procedures
* Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study
* Subject is pregnant or breast feeding
* Subject is not using adequate contraceptive precautions
* Subject has known sensitivity to any recombinant E. coli-derived product
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative
* Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures
B: Inclusion criteria:

* Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count.
* Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
* Normal PT and PTT.

Exclusion criteria:

* History of clotting disorder.
* Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.
* History of alcohol/drug abuse or dependence within 1 year.
* Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
* History of HIV infection or active infection with Hepatitis B or C.
C: Inclusion Criteria:

* Must have previously completed a romiplostim ITP study
* Platelet count ≤ 50 x 10 \^9/L
* Written informed consent

Exclusion Criteria:

* Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
* Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
* Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
* Not using adequate contraceptive precautions
* Not available for follow-up assessments
* Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures.
D: Inclusion Criteria:

* Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F)
* Have had a splenectomy for the treatment of ITP greater than or equal to 24 weeks prior to study entry
* Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
* The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be:
* \* less than 30 x 10\^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10\^9/L,
* \* less than 50 x 10\^9/L for those subjects receiving a constant dose schedule of corticosteroids, azathioprine or danazol with no count greater than 55 x 10\^9/L
* A serum creatinine concentration less than or equal to 2 mg/dl(less than or equal to 176.8 µmol/L)
* Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range
* Hemoglobin greater than 11.0 g/dL
* Written informed consent (see Section 12.1)

Exclusion Criteria:

* Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study)
* 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 randomization
* Documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year
* History of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy
* Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 100 mmHg\] or cardiac arrhythmia)
* Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker; using oral contraceptives; on estrogen therapy; known positive for anti-phospholipid antibodies; hypertriglyceridemia; hypercholesteremia (greater than 240 mg/dL); treatment for hypertension
* Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
* Currently receiving any treatment for ITP except corticosteroids, azathioprine or danazol administered at a constant dose and schedule
* IV Ig or anti-D Ig within 2 weeks before the screening visit
* Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
* Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
* Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531 or related platelet product
* Received any aklylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
* Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
* Less than 8 weeks since major surgery
* Pregnant or breast feeding
* Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
* Known hypersensitivity to any recombinant E coli-derived product
* Concerns for subject's compliance with the protocol

Answer: A