Status:
COMPLETED
Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)
Lead Sponsor:
Amgen
Conditions:
Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate changes in bone marrow morphology (structure) after long-term exposure to romiplostim.
Detailed Description
Participants diagnosed with ITP according to the American Society of Hematology (ASH) Guidelines were sequentially enrolled into the following groups: * Bone marrow biopsy at Baseline and Year 1 * Bo...
Eligibility Criteria
Inclusion
- 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
- Subject ≥18 years of age
- 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 \< 50 x 10\^9/L
- Must have received at least 1 prior ITP therapy (examples of ITP therapy include corticosteroids, intravenous immunoglobulin \[IVIG\], splenectomy)
- Subject (or legally-acceptable representative) is willing and able to provide written informed consent
Exclusion
- 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)
- Subject has participated in any study evaluating pegylated recombinant human megakaryocyte growth and development factor (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
- 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.
Key Trial Info
Start Date :
August 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2014
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00907478
Start Date
August 11 2009
End Date
January 14 2014
Last Update
September 21 2022
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