Thrombocytopenia in pediatric subjects with ITP---------Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI) MedDRA version: 12.0 Level: LLT Classification code 10043558 Term: Thrombocytopenia purpura
Conditions
Interventions
Product Name: NPLATE
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ROMIPLOSTIM
Other descriptive name: ROMIPLOSTIM
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ethical - Subject or subject's legally acceptable representative has provided informed consent. Demographic - Subject is less than 18 years old at time of screening. Disease-Related - Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related - 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. Medications - Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study. General - 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). - Subject (male or female) is not willing to use highly effective contraception during treatment if and when sexually active and for 4 weeks (women) or 14 weeks (men) after the end of treatment. - Subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment. - Male subject with a pregnant partner who is not willing to use a condom if and when sexually active during treatment and for 14 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety of romiplostim as a long-term treatment in pediatric thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura (ITP).;Secondary Objective: This study will also evaluate the long-term platelet response to romiplostim as well as the possible reductions in the dose of concurrent ITP therapies while receiving romiplostim.;Primary end point(s): The primary endpoints are the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. | — |
Countries
Spain
Outcome results
None listed