At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
tbo-filgrastimdrug
Likely dose
tbo-filgrastim 5 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 ?g/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jul 15, 2014·Updated Dec 10, 2021
In Brief
A Phase 2 clinical trial evaluating tbo-filgrastim for Neutropenia. Completed, enrolled 50 participants across 33 sites in 8 countries.
Detailed Summary
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without bone marrow involvement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia
CountriesBulgaria, Croatia, Hungary, Poland, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartMay 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedJul 15, 2014
Enrollment StartMay 12, 2015
Primary CompletionApr 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.0 years ago
Interventions
tbo-filgrastimdrug
5 μg/kg