A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura
NCT ID: NCT01071954
Last Updated: 2020-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
66 participants
INTERVENTIONAL
2009-12-30
2017-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Romiplostim
Participants received romiplostim administered by subcutaneous injection once a week. The starting dose of romiplostim was 1 μg/kg; weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of between 50 x 10\^9/L and 200 x 10\^9/L.
Romiplostim
Administered by subcutaneous injection once a week.
Interventions
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Romiplostim
Administered by subcutaneous injection once a week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.
Exclusion Criteria
* Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study.
* Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study.
* Other investigational medications are excluded.
* 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) (with the exception of romiplostim in a previous clinical study).
* Female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment.
* Female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment.
* Subject has known sensitivity to any of the products to be administered during dosing.
* Subject previously has entered this study (this will depend on the type of study).
* Subject will not be available for protocol required study visits, to the best of the subject 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.
1 Year
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Iowa City, Iowa, United States
Research Site
Louisville, Kentucky, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Kansas City, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Randwick, New South Wales, Australia
Research Site
South Brisbane, Queensland, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Barcelona, Catalonia, Spain
Countries
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References
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Tarantino MD, Bussel JB, Blanchette VS, Beam D, Roy J, Despotovic J, Raj A, Carpenter N, Mehta B, Eisen M. Long-term treatment with romiplostim and treatment-free platelet responses in children with chronic immune thrombocytopenia. Haematologica. 2019 Nov;104(11):2283-2291. doi: 10.3324/haematol.2018.202283. Epub 2019 Mar 7.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2009-016203-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20090340
Identifier Type: -
Identifier Source: org_study_id
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