Trials / Completed
CompletedNCT02190721
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 1 Month – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tbo-filgrastim | 5 μg/kg |
Timeline
- Start date
- 2015-05-12
- Primary completion
- 2017-04-04
- Completion
- 2017-04-04
- First posted
- 2014-07-15
- Last updated
- 2021-12-10
- Results posted
- 2018-07-31
Locations
33 sites across 8 countries: United States, Bulgaria, Croatia, Hungary, Poland, Romania, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02190721. Inclusion in this directory is not an endorsement.