An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria
• Subject is = 18 years of age
• Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura
per the American Society of Hematology guidelines
• Subject had a bone marrow biopsy and aspirate consistent with ITP
conducted within 2 years of Screening
• Subject’s platelet count is = 20 x10^9/L or the subject is experiencing bleeding
that is uncontrolled with conventional therapies
• Subject has failed at least 3 conventional therapies for ITP and, in the opinion of
the treating physician, is unlikely to respond to other available therapies
• If a subject has a history of atrial fibrillation, subject is currently receiving
anti-coagulation medication
• Subject (or legally-acceptable representative) is willing and able to provide
written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
• Subject has a history of arterial thrombosis (eg, cerebrovascular accident,
transient ischemic attack, or myocardial infarction)
• Subject has a history of venous thrombosis (eg, deep vein thrombosis,
pulmonary embolism)
• Subject has a history of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or any other systemic infectious disease known to cause severe thrombocytopenia
• Subject has a history of disseminated intravascular coagulation or underlying hypercoaguable state
• Subject has a history of any of the following autoimmune disorders: systemic lupus erythematosis, Evans Syndrome, autoimmune neutropenia, lupus anticoagulant or antiphospholipid antibody syndrome, or active vasculitis
• Subject has a history of microangiopathic hemolytic anemia (ie, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura)
• Subject has active lymphoproliferative or immunoproliferative (monoclonal
gammopathy of undeterimined significance, multiple myeloma) disorder or
leukemia
• Subject has a history of a myeloproliferative disorder (eg, myelofibrosis, chronic myelogenous leukemia)
• Subject has myelodysplastic syndrome
• Subject with a history of exposure to mutagenic chemotherapy has either dysplastic cytological findings or abnormal cytogenetics on bone marrow study
• Subject has a history of paroxysmal nocturnal hemoglobinuria
• Subject has participated in any study evaluating PEG-rHuMGDF, recombinant
human thrombopoietin (rHuTPO), or related platelet product
• Subject has a known hypersensitivity to any recombinant E coli-derived product
• Subject has received any therapeutic drug or device that is not approved
by the local regulatory health agency for any indication within 4 weeks of Screening
• Subject is of reproductive potential and is not using adequate contraceptive
precautions, in the judgment of the investigator
• Subject is pregnant or breast feeding
• Investigator has concerns regarding the subject’s ability to comply with the protocol procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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