An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000638-37-IT
• Date of registration: 04/08/2008
• Prospective Registration: No
• Primary sponsor: AMGEN S.P.A.
• Public title: An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209
• Scientific title: An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209
• Date of first enrolment: 09/06/2008
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000638-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Czech Republic, Ireland, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subject is ≥ 18 years of age Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines (see Appendix B) Subject had a bone marrow biopsy and aspirate consistent with ITP conducted within 2 years of Screening Subject?s platelet count is ≤ 20 x109/L or the subject is experiencing bleeding that is uncontrolled with conventional therapies Subject has failed at least 3 conventional therapies for ITP and, in the opinion of the treating physician, isunlikely to respond to other available therapies If a subject has a history of atrial fibrillation, subject is currently receiving anti-coagulation medication 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

Exclusion criteria:
Subject has a history of arterial thrombosis (eg, cerebrovascular accident, transient ischemic attack, myocardial infarction) Subject has a history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) Subject has a history of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or any other systemic infectious disease known to cause severe thrombocytopenia Subject has a history of disseminated intravascular coagulation or underlying hypercoaguable state Subject has a history of any of the following autoimmune disorders: systemic lupus erythematosis, Evans Syndrome, autoimmune neutropenia, lupus anticoagulant or antiphospholipid antibody syndrome, or active vasculitis Subject has a history of microangiopathic hemolytic anemia (ie, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura) Subject has active lymphoproliferative or immunoproliferative (monoclonal gammopathy of undeterimined significance, multiple myeloma) disorder or leukemia Subject has a history of a myeloproliferative disorder (eg, myelofibrosis, chronic myelogenous leukemia) Subject has myelodysplastic syndrome Subject with a history of exposure to mutagenic chemotherapy has either dysplastic cytological findings or abnormal cytogenetics on bone marrow study Subject has a history of paroxysmal nocturnal hemoglobinuria Subject has participated in any study evaluating PEGrHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product Subject has a known hypersensitivity to any recombinant E coli-derived product Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator Subject is pregnant or breast feeding Investigator has concerns regarding the subject?s ability to comply with the protocol procedures


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Thrombocytopenia in subjects with ITP
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura

Intervention(s)

Product Name: AMG531
Product Code: AMG531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Primary end point(s): Primary Objective To demonstrate the safety of AMG 531 in severely refractory thrombocytopenic subjects with ITP

Main Objective: To demonstrate the safety of AMG 531 in severely refractory thrombocytopenic subjects with ITP

Secondary Objective: To monitor hematological responses to AMG 531 To provide open-label use of AMG 531, and to investigate its utility in severely refractory thrombocytopenic subjects with ITP who do not qualify for any ongoing ITP studies with AMG 531

Secondary ID(s)

20040209

2007-000638-37-NL