An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000638-37-IE
• Date of registration: 10/04/2008
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Scientific title: An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Date of first enrolment: 06/01/2009
• 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: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

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

Key inclusion & exclusion criteria

Inclusion 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
• Subject had a bone marrow biopsy and aspirate consistent with ITP
conducted within 2 years of Screening
• Subject’s platelet count is = 20 x10^9/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, is unlikely 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:
Exclusion Criteria
• Subject has a history of arterial thrombosis (eg, cerebrovascular accident,
transient ischemic attack, or 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 PEG-rHuMGDF, 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

Immune (Idiopathic) Thrombocytopenic Purpura
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura

Intervention(s)

Product Name: AMG 531
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the incidence of adverse events, including clinically significant
changes in laboratory values and incidence of antibody formation.

Main Objective: The primary objective of this study is to evaluate the safety of AMG 531 in severely refractory thrombocytopenic subjects with ITP.

Secondary Objective: This study will also evaluate hematological responses to AMG 531. In addition, the study will provide open label use of AMG 531, and will investigate its utility in severely refractory thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura (ITP) who do not qualify for any ongoing ITP studies
using AMG 531.

Secondary ID(s)

2007-000638-37-NL

20040209