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A phase III, open label study of FPF3401 in patients with hyposelenemia

A phase III study of FPF3401

Urabe Hiromi

Fujimoto Pharmaceutical Corporation

1-3-40 Nishiotsuka Matsubara Osaka

h-urabe@fujimoto-pharm.jp

Urabe Hiromi

Fujimoto Pharmaceutical Corporation

1-3-40 Nishiotsuka Matsubara Osaka

+81-72-332-5151

h-urabe@fujimoto-pharm.jp

Complete

July. 22, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Hyposelenemia

FPF3401 is administered orally or by tube once daily. The dose of FPF3401 is adjusted depending on the patient's condition.

A rate of cases with serum selenium concentrations reaching and being maintained at the reference interval.

Safety etc.

+81-29-853-3914

June. 14, 2022

No

none