Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Intervention: Romiplostim
Intervention description: Romiplostim will be administered weekly by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ITP

Summary:

      The purpose of this study is to describe the number of months with a platelet response over a
      12 month treatment period and to describe ITP remission rates in adults with ITP receiving
      romiplostim.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject has been diagnosed with primary ITP according to the American Society of
        Hematology (ASH) guidelines (George et al, 1996) and previously received only 1st line
        therapies.

        First line therapy is defined as corticosteroids, immunoglobulin G (IVIG), anti-D and vinca
        alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet
        transfusion at any time during the six month period since the original diagnosis would not
        exclude the subject from study participation

          -  Initial diagnosis of primary ITP within 6 months of enrollment

          -  Age ≥ 18 years at screening

          -  A single platelet count ≤ 30 x 10⁹/L at any time during the screening period

          -  Subject or subject's legally acceptable representative has provided informed consent

        Exclusion Criteria:

          -  Known history of a bone marrow stem cell disorder

          -  Surgical resection of the spleen

          -  Subject has a history of cancer or current malignancy other than basal cell carcinoma
             or cervical cancer in-situ with active treatment or disease within 5 years of
             screening

          -  Known history of congenital thrombocytopenia

          -  Known history of hepatitis B, hepatitis C, or human immunodeficiency virus

          -  Positive H. pylori by urea breath test or stool antigen test at screening

          -  Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune
             neutropenia

          -  Known history of antiphospholipid antibody syndrome or positive for lupus
             anticoagulant

          -  Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or
             thrombotic thrombocytopenic purpura

          -  Previous history of recurrent venous thromboembolism or thrombotic events or an
             occurrence within 5 years of enrollment.

          -  Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and
             development factor (PEG-rHuMGDF), eltrombopag, recombinant human thrombopoietin
             (rHuTPO) or any platelet producing agent

          -  Rituximab (for any indication) or mercaptopurine (6-MP) or anticipated use during the
             time of the proposed study

          -  All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within
             4 weeks before the screening visit

          -  Alkylating agents use at any time before or during the screening visit or anticipated
             during the time of the proposed study

          -  Known hypersensitivity to any recombinant E. coli-derived product (eg, Infergen,
             Neupogen, Somatropin, and Actimmune)

          -  Currently enrolled in another investigational device or drug study, or less than 30
             days since ending another investigational device or drug study(s), or receiving other
             investigational agent(s)

          -  Subject will have any other investigational procedures performed while enrolled in
             this clinical study

          -  Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks
             after the end of treatment

          -  Female subject of child bearing potential is not willing to use, in combination with
             her partner, highly effective contraception during treatment and for 4 weeks after the
             end of treatment

          -  Subject has previously enrolled into a romiplostim study

          -  Subject will not be available for protocol required study visits, to the best of the
             subject's and investigator's knowledge

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures