Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura
Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP research study
What is the primary objective of this study?
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic subjects with Immune (Idiopathic) Thrombocytopenia Purpura. This study is available to pediatric subjects who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.
Who is eligible to participate?
Inclusion Criteria: - Subject or subject's legally acceptable representative has provided informed consent. - Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP. Exclusion Criteria: - Subject has or previously had any 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). - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:RomiplostimStarting Dose of 1µg/kg romiplostim or previous dose administered weekly Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count Rescue Medications Allowed at Discretion of Investigator Reduction in Concurrent ITP Therapies May Occur when Platelet Count is >50 x 109/L
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Single ArmStarting Dose of 1µg/kg romiplostim or previous dose administered weekly Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count
Start Date: December 30, 2009
Completed Date: January 12, 2017
Phase: Phase 3
Primary Outcome: the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.
Secondary Outcome: Platelet response to romiplostim defined as platelet counts 50x109/L in the absence of rescue medication.
Study sponsors, principal investigator, and references
Principal Investigator: MD
Lead Sponsor: Amgen