A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim. - Romiplostim 20080435

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

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 4.1.2 Initial diagnosis of primary ITP within 6 months of enrollment 4.1.3 Age = 18 years at screening 4.1.4 A single platelet count = 30 x 109/L at any time during the screening period 4.1.5 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:
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

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 4.2.2 Surgical resection of the spleen 4.2.3 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 4.2.4 Known history of congenital thrombocytopenia 4.2.5 Known history of hepatitis B, hepatitis C, or human immunodeficiency virus 4.2.6 Positive H. pylori by urea breath test or stool antigen test at screening 4.2.7 Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia 4.2.8 Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant 4.2.9 Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura 4.2.10 Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment. 4.2.11 Previous use of romiplostim, PEG-rHuMGDF, eltrombopag, rHuTPO or any platelet producing agent 4.2.12 Rituximab (for any indication) or Mercaptopurine (6-MP) or anticipated use during the time of the proposed study 4.2.13 All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before the screening visit 4.2.14 Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study 4.2.15 Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune) 4.2.16 Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) 4.2.17 Subject will have any other investigational procedures performed while enrolled in this clinical study 4.2.18 Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment 4.2.19 Female subject of child bearing potential is not willing to use, in combination with her partner, highly effective contraception during treatment and for 5 months after the end of treatment 4.2.20 Subject has previously enrolled into a romiplostim study 4.2.21 Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge 4.2.22 Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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