Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Conditions
Interventions
Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Romiplostim
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion 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 • If subject is >60 years of age, subject has written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP •Subject has received at least 1 prior therapy for ITP • Subject's platelet count is =30 x10^9/L or subject is experiencing bleeding that is uncontrolled with conventional therapies • 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: Exclusion Criteria • Subject has a history of hematological malignancy, myeloproliverative disorder, MDS, or bone marrow stem cell disorder • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety of Romiplostim in adult thrombocytopenic subjects with ITP.;Secondary Objective: This study will also evaluate hematological responses to Romiplostim. ;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. | — |
Countries
Austria, Belgium, Czech Republic, Ireland, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed