Intervention: HYDROCHLORIC ACID
Trial phase: Phase 2
ATC code: A09AB03 | B05XA13
SMILES: Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
Have completed at least 1 prior treatment for ITP

Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:

less than 30 x 10^9/L for those subjects not receiving any ITP therapy,
less than 50 x 10^9/L for those subjects receiving any ITP therapy
Eastern Cooperative Oncology Group performance status of 0 to 2
Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
Adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range
Hemoglobin greater than 10.0 g/dL
Written informed consent

Exclusion Criteria:

Considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period
Any known history of bone marrow stem cell disorder
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 (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (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; hypercholesteremia (> 240 mg/dL); treatment for hypertension
Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit
Received intravenous (IV) immunoglobulin (Ig) or WinRho within 2 weeks before the screening visit
Received hematopoietic growth factors, including interleukin (IL)-11 (Neumega®) within 4 weeks before the screening visit
Past or present participation in any study evaluating polyethylene glycol recombinant human magakaryopoiesis differentiating factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), or related platelet product
Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
Received any monoclonal antibody (eg, rituximab) within 16 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 2 months since major surgery (including laparoscopic splenectomy)
Pregnant or breast feeding
Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator