A phase III study of FPF3401

JRCT ID: jRCT2031220210

Registered date:09/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hyposelenemia
• Date of first enrollment: 22/07/2022
• Target sample size: 53
• Study type: Interventional
• Intervention(s): FPF3401 is administered orally or by tube once daily. The dose of FPF3401 is adjusted depending on the patient's condition.

Outcome(s)

• Primary Outcome: A rate of cases with serum selenium concentrations reaching and being maintained at the reference interval.
• Secondary Outcome: Safety etc.

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Urabe Hiromi