Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.·Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment 2. Have completed at least 1 prior treatment for ITP (eg, prednisone) 3. Subjects > 60 years of age must have a minimum of one year documented history of chronic ITP with a bone marrow report to confirm the diagnosis 4. The mean of the three platelet counts taken during the screening and pre-treatment periods must be = 30 x 109/L, with no individual count > 35 x 109/L 5. Subjects must be greater than or equal to 18 years of age at the time of obtaining the informed consent 6. A serum creatinine concentration less than or equal to 2 mg/dl (less than or equal to 176.8 mmol/L) 7. Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range 8. Hemoglobin = 9.0 g/dL 9. Before any study-specific procedure, the appropriate written informed consent must be obtained 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
Exclusion criteria
Exclusion criteria: 1. Have had a Splenectomy for any reason 2. Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study) 3. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization 4. Currently receiving any treatment for ITP, except corticosteroids, azathioprine, or danazol administered at a constant dose and schedule 5. IV Ig or anti-D Ig within 2 weeks before the screening visit 6. Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study 7. Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit 8. Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study 9. 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 investigational agent(s) other than AMG 531 10. Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or related platelet product 11. Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding 12. Subject is not using adequate contraceptive precautions 13. Known hypersensitivity to any recombinant E coli -derived product 14. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters.; Secondary Objective: To evaluate the overall safety of AMG 531 To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531 To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531 ; Primary end point(s): The primary endpoint is the incidence of durable platelet response. A subject with durable platelet response is defined as achieving at least 6 weekly platelet responses during the last 8 weeks of treatment in the absence of rescue medication. A weekly platelet response is defined as a platelet count of = 50 x 109/L on the weekly scheduled dose day from week 2 to week 25. | — |
Countries
Spain, United Kingdom
Outcome results
None listed