An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Condition: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Romiplostim
Intervention description: Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Platelet; AMG 531; Thrombopoietin; blood disorder; bleeding disorder; immune thrombocytopenic purpura; idiopathic thrombocytopenic purpura; immune (idiopathic) thrombocytopenic purpura; TPO; thrombopoietic protein

Summary:

      This protocol will provide open label romiplostim to adult thrombocytopenic subjects.
      Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment
      will be based on platelet counts, and will be allowed throughout the duration of the study.
      Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP
      therapies may occur at any time when platelet counts are > 50,000.
    

Eligibility 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

          -  If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or
             biopsy report consistent with a diagnosis of ITP

          -  Subject has received at least 1 prior therapy for ITP

          -  Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is
             uncontrolled with conventional therapies

          -  Subject (or legally-acceptable representative) is willing and able to provide written
             informed consent

        Exclusion Criteria:

          -  Subject has a history of hematological malignancy, myeloproliferative disorder,
             myelodysplastic syndrome (MDS), or bone marrow stem cell disorder

          -  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