Hyposelenemia
Conditions
Interventions
FPF3401 is administered orally or by tube once daily. The dose of FPF3401 is adjusted depending on the patient's condition.
Sponsors
Urabe Hiromi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Previously untreated patients 1)Patients with hyposelenemia or suspected hyposelenemia. 2)Patients having capability of intestinal absorption of selenium. 3)Patients on enteral nutrition therapy or diet therapy. 4)Patients with serum selenium concentrations below the reference value. High-dose treatment patients 1)Patients with hyposelenemia or suspected hyposelenemia. 2)Patients daily treated with high-dose selenium preparations by oral or tube administration. 3)Patients having capability of intestinal absorption of selenium.
Exclusion criteria
Exclusion criteria: Previously untreated patients 1)Patients mainly treated with their nutrition intravenously. 2)Patients treated with any of the following drugs. (1)Selenium preparations (2)Teduglutide 3)Patients allergic to selenium. High-dose treatment patients 1)Patients treated with any of the following drugs. (1)Selenium preparations (except for oral or tube administration) (2)Teduglutide 2)Patients allergic to selenium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A rate of cases with serum selenium concentrations reaching and being maintained at the reference interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety etc. | — |
Contacts
Public ContactHiromi Urabe
Fujimoto Pharmaceutical Corporation
Outcome results
None listed