Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
- Conditions
- Adult immune thrombocytopenic purpura (ITP)MedDRA version: 14.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-019987-35-DE
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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
F.1.3.1 Number of subjects for this age range 75
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.
11. Previous use of romiplostim, PEG-rHuMGDF, eltrombopag, rHuTPO or any platelet producing agent
12. Rituximab (for any indication) or Mercaptopurine (6-MP) or anticipated use during the time of the proposed study
13. All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before the screening visit.
14. Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study
15. Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen®, Neupogen®, Somatropin, and Actimmune)
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)
17. Subject will have any other investigational procedures performed while enrolled in this clinical study
18. Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment
19. 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
20. Subject has previously enrolled into a romiplostim study
21. Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
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 Main Objective: The primary objective is to describe the number of months with a subject platelet response over a 12 month treatment period.;Secondary Objective: • The subject incidence of immune thrombocytopenic purpura (ITP) remission<br>• The subject incidence of splenectomy<br>• The subject incidence of adverse events;Primary end point(s): The primary endpoint is the number of months with platelet response during the 12 month treatment period. A platelet response during any one month is defined as the median of platelet counts measured in the month = 50 x 109/L.;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Subject incidence of ITP remission during the 12 month treatment or tapering period of the study. An ITP remission is defined as maintaining every platelet count = 50 x 109/L for at least 6 months in the absence of romiplostim and any medication for ITP (concomitant or rescue) through discontinuation<br>• The incidence of splenectomy during the 12 month treatment period<br>• Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation at any time during the study;Timepoint(s) of evaluation of this end point: 12 months