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).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)?
- Conditions
- Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)MedDRA version: 9.1Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
- Registration Number
- EUCTR2008-004347-10-ES
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 169
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