臨床研究等提出・公開システム

FPF3400 long-term study in patients who require selenium supplementation - A multicenter open study -

FPF3400 long-term study in patients who require selenium supplementation - A multicenter open study -

50

The FAS (49 subjects) were male 59.2% and female 40.8%, and 10 subjects between 1 and 5 years old, 11 subjects between 6 and 11 years old, 7 subjects between 12 and 18 years old, and 21 subjects aged 19 years or older.

In total 50 subjects received the study drug, and 25 subjects continued receiving the drug until the date of the approval of the study drug for marketing and manufacturing. One subject in the category between 1 and 5 years old was completely excluded from the analysis due to a serious GCP violation.

Adverse events occurred in 48 out of 49 subjects (98.0%), and side effects in 10 cases (20.4%). Serious adverse events occurred in 43 subjects (87.8%). Among them, one drug-related serious adverse event recognized in 1 subject was malaise. Fatal adverse events occurred in 4 subjects, but any causal relationship with the study drug was ruled out for the respective cases.

A rate of patients whose serum selenium concentrations at the respective assessment times had maintained within the range of the normal level varied from 40.0% to 100.0%.

The pre-administration serum selenium concentration was 7.88 plus or minus 2.41, and the concentration at the final evaluation was 9.82 plus or minus 1.85, with a statistically significant elevation (microgram/dL, mean plus or minus standard deviation). In some subjects, certain improvement in clinical findings (nail, hair, grip strength, lower limb muscle strength, muscle pain) was observed.

The tendency was observed that long term administration of FPF3400 could lead to maintenance of a serum selenium concentration within the range of the normal level in patients under the state of requiring selenium supplementation, and there were no serious safety problems with FPF3400.

Mar. 10, 2019

https://mol.medicalonline.jp/archive/search?jo=aa9syrsc&ye=2019&vo=68&issue=3

No

Fujimoto Pharmaceutical Corporation

kaihatsu3@fujimoto-pharm.co.jp

Fujimoto Pharmaceutical Corporation

kaihatsu3@fujimoto-pharm.co.jp

completed

May. 23, 2013

Interventional

A multicenter open study

treatment purpose

3

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

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

Both

Hyposelenemia

investigational material(s)
Generic name etc : FPF3400
INN of investigational material : -
Therapeutic category code : 32- Nutrients, tonics and alteratives
Dosage and Administration for Investigational material : intravenous injection

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
A rate of patients whose serum selenium concentrations at the respective assessment times had maintained within the range of the normal level

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

Feb. 27, 2013