Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
Condition: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Medical Standard of Care for ITP; Romiplostim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: splenectomy; platelet; AMG 531; thrombopoietin; blood disorder; bleeding disorder; immune thrombocytopenic purpura; idiopathic thrombocytopenic purpura; immune (idiopathic) thrombocytopenic purpura; TPO; thrombopoietic protein

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.
    

Eligibility criteria:

        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