Hyposelenemia
Conditions
Sponsors
Fujimoto Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main selection criteria [ Patients under intravenous administration of FPF3400 continuously from the previous Phase 3 Study ] Patients who require FPF3400 administration continuously from the previous Phase 3 Study Patients who require TPN therapy for over 6 months [ Patients for whom treatment has been switched from a hospital selenium formulation to the investigational drug of central vein injection ] Patients who are currently under central vein administration of the selenium formulation and can receive the treatment continuously Patients under the TPN therapy only or under the TPN therapy combined with the enteral nutrition only Patients who require TPN therapy for over 6 months Patients who can be hospitalized for a fixed period [ Patients to whom intravenous administration of FPF3400 has been started ] Patients to whom daily intravenous administration can be performed at least for one week Patients who can be hospitalized for a fixed period Patients whose serum selenium concentrations are below the lower limit of the normal range
Exclusion criteria
Exclusion criteria: Main exclusion criteria [ Patients under intravenous administration of the investigational drug continuously from the previous Phase 3 Study ] Patients who were withdrawn from the previous Phase 3 Study Patients during pregnancy or breastfeeding, or patients who wish to get pregnant during the study [Patients for whom treatment has been switched from a hospital selenium formulation to the investigational drug of central vein injection ] Patients who have hypersensitivity to selenium and other components Patients during pregnancy or breastfeeding, or patients who wish to get pregnant during the study [ Patients to whom intravenous administration of FPF3400 has been started ] Patients who have hypersensitivity to selenium and other components Patients during pregnancy or breastfeeding, or patients who wish to get pregnant during the study Patients who had received FPF3400 treatment in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy A rate of patients whose serum selenium concentrations at the respective assessment times had maintained within the range of the normal level | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1. Efficacy evaluation (1) A time length during which a serum selenium concentration has been maintained within the normal range (2) A dose required to maintain a normal level of serum selenium concentration (3) Time course of serum selenium concentrations (4) Rate of patients who have recovered their serum selenium concentrations over the lower limit of the normal range (5) Time course of plasma GSH-Px activities (6) 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