View Clinical Trial (Medical Research Study)
A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
| City: |
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Hickory |
| State: |
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North Carolina |
| Zip Code: |
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28602 |
| Conditions: |
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Idiopathic Thrombocytopenic Purpura |
| Purpose: |
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The purpose of this study is to describe the number of months with a subject platelet
response over a 12 month treatment period and to describe ITP Remission Rates in Adult
Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim
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| Study Summary: |
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| Criteria: |
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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
- 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 Criteria:
- 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, PEG-rHuMGDF, eltrombopag, 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 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 5 months 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
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| NCT ID: |
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NCT01143038 |
| Primary Contact: |
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Study Director
MD
Amgen
Amgen Call Center
Phone: 866-572-6436
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hickory, North Carolina 28602
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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