Thrombocytopenia associated with ITP MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Conditions
Interventions
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Romiplostim
Current Sponsor code: AMG 531
Concentration u
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease related • Diagnosis of ITP according to American Society of Hematology (ASH) guidelines • Subject must have had a bone marrow biopsy within one year prior to planned first dose of romiplostim (with available bone marrow tissue block or unstained histological slides to send to a central laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy within 3 weeks prior to planned first dose of romiplostim. Central laboratory interpretation is required prior to first dose of romiplostim • Subject must agree to a scheduled bone marrow biopsy at Year 1, Year 2, or Year 3 following romiplostim treatment and any unscheduled biopsies if clinically indicated Demographic • Subject > 18 years of age Laboratory • Baseline bone marrow reticulin grade of 0, 1, 2, or 3 according to the modified Bauermeister grading scheme as assessed by central laboratory interpretation • Platelet count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related • Baseline bone marrow biopsy positive for collagen fibrosis • Any known history of or currently active bone marrow stem cell disorder, hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome • Any current active malignancy • Any prior exposure to cytostatic chemotherapy or radiotherapy for malignancy • Subject has undergone pacemaker placement, cardiac ablation of arrhythmia, and/or any current treatment with Vaughan Williams Class IA – IC and Class III agents (Vaughan Williams, 1970) Medications • Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or thrombopoietin receptor agonists (ie romiplostim or eltrombopag) • Subject has a known hypersensitivity to any recombinant E coli-derived product General • Subject is currently enrolled in or has not yet completed (at least 4 weeks since ending) other investigational device or drug trial(s) or subject is receiving other investigational agent(s) • Other investigational procedures are excluded • Subject of child-bearing potential is evidently pregnant (eg positive pregnancy test) or is breast feeding • Subject is not using adequate contraceptive precautions • 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 and/or is unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the incidence of collagen fibrosis as evidenced by trichrome staining at Year 1, Year 2, or Year 3 after initial exposure of romiplostim.;Secondary Objective: To evaluate the presence of collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in subjects who developed collagen fibrosis at Year 1, Year 2, or Year 3 after exposure of romiplostim. To evaluate the incidence of increased reticulin fibrosis as evidenced by silver staining at Year 1, Year 2, or Year 3 after exposure of romiplostim. To evaluate electrocardiogram (ECG) changes after exposure to romiplostim. To evaluate the incidence of cytopenias (anemia or neutropenia) after exposure to romiplostim. To evaluate the overall safety as evidenced by adverse events and the development of neutralizing antibodies to romiplostim or cross-reacting antibodies to endogenous thrombopoietin.;Primary end point(s): The primary endpoint is the incidence of collagen fibrosis as evidenced by trichrome staining at Years 1, 2, or 3 after initial romiplostim exposure using the modified Bauermeister grading scale. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Italy, Lithuania, Poland, Slovenia, Spain, Sweden
Outcome results
None listed