A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim

Amgen Inc0 sites75 target enrollmentAugust 26, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2010

End Date

December 26, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1 Subject has been diagnosed with primary ITP according to the ASH guidelines (George et al, 1996\) and previously received only 1st line therapies. First line therapy is defined as corticosteroids, IVIG, Anti\-D and Vinca Alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet transfusion at any time during the six month period since the original diagnosis would not exclude the subject from study participation
•2\. Initial diagnosis of primary ITP within 6 months of enrollment
•3\. Age \= 18 years at screening
•4\. A single platelet count \= 30 x 109/L at any time during the screening period
•5\. Subject or subject’s legally acceptable representative has provided informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 75
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Known history of a 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
•2\. Surgical resection of the spleen
•3\. Subject has a history of cancer or current malignancy other than basal cell carcinoma or cervical cancer in\-situ with active treatment or disease within 5 years of screening
•4\. Known history of congenital thrombocytopenia
•5\. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus
•6\. Positive H. pylori by urea breath test or stool antigen test at screening
•7\. Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
•8\. Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant
•9\. Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
•10\. Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment.