Hyposelenemia
Conditions
Sponsors
Fujimoto Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main selection criteria Patients under only TPN therapy or under TPN and the enteral nutrition (EN) therapy in whom contents of EN have not been changed for last 4 weeks prior to initiation of FPF3400 administration, and the same contents are expected to be continued Patients who can be hospitalized for a fixed period Patients whose serum selenium concentrations are below the lower limit of the normal range Patients who require TPN therapy for longer than 4 weeks In case of infant patients with milk nutrition, for whom contents of milk have not been changed for last 4 weeks prior to initiation of FPF3400 administration
Exclusion criteria
Exclusion criteria: Main exclusion criteria Patients who have hypersensitivity to selenium and other components Patients who took a hospital selenium preparation, a selenium compounded formulation, or some selenium supplementary foods for last 4 weeks prior to initiation of FPF3400 administration Patients during pregnancy or breastfeeding, or patients who wish to get pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from a baseline of serum selenium concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Efficacy evaluation (1) Time course of serum selenium concentrations (2) Rate of patients who have recovered their serum selenium concentrations over the lower limit of the normal range (3) Time course of plasma GSH-Px activity (4) Rate of improvement in clinical findings 2.Safety evaluation (1) Laboratory tests (2) The standard 12-lead electrocardiogram (3) Echocardiography (when necessary) (4) Vital signs and body weight (5) Adverse events | — |
Countries
Japan
Outcome results
None listed