Status:
COMPLETED
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
Lead Sponsor:
Amgen
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
Detailed Description
The study includes a 4-week screening period, a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. During the 12-month treatment period romiplostim doses could be increase...
Eligibility Criteria
Inclusion
- \- Subject has been diagnosed with primary ITP according to the American Society of Hematology (ASH) guidelines (George et al, 1996) and previously received only 1st line therapies.
- First line therapy is defined as corticosteroids, immunoglobulin G (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
- Initial diagnosis of primary ITP within 6 months of enrollment
- Age ≥ 18 years at screening
- A single platelet count ≤ 30 x 10⁹/L at any time during the screening period
- Subject or subject's legally acceptable representative has provided informed consent
Exclusion
- Known history of a bone marrow stem cell disorder
- Surgical resection of the spleen
- 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
- Known history of congenital thrombocytopenia
- Known history of hepatitis B, hepatitis C, or human immunodeficiency virus
- Positive H. pylori by urea breath test or stool antigen test at screening
- Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
- Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant
- Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
- Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment.
- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent
- Rituximab (for any indication) or mercaptopurine (6-MP) or anticipated use during the time of the proposed study
- All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within 4 weeks before the screening visit
- Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study
- Known hypersensitivity to any recombinant E. coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
- 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)
- Subject will have any other investigational procedures performed while enrolled in this clinical study
- Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment
- Female subject of child bearing potential is not willing to use, in combination with her partner, highly effective contraception during treatment and for 4 weeks after the end of treatment
- Subject has previously enrolled into a romiplostim study
- Subject will not be available for protocol required study visits, to the best of the subject's and investigator's knowledge
- 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
Key Trial Info
Start Date :
November 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01143038
Start Date
November 30 2010
End Date
December 26 2013
Last Update
September 21 2022
Active Locations (48)
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1
Research Site
Anaheim, California, United States, 92801
2
Research Site
Orange, California, United States, 92868
3
Research Site
Boynton Beach, Florida, United States, 33435
4
Research Site
Bethesda, Maryland, United States, 20817