A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)
- Conditions
- Thrombocytopenia associated with ITPMedDRA version: 9.1Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
- Registration Number
- EUCTR2008-004347-10-SE
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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 < 50x 109/L
Medications
• Must have received at least 1 prior ITP therapy (examples of ITP therapy include
corticosteroids, IVIG, splenectomy)
Ethical
• Subject (or legally-acceptable representative) is willing and able to provide written
informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method