臨床研究等提出・公開システム

A Phase III study of NPC-25 in pediatric patients with hypozincemia (NPC-25-6)

A Phase III study of NPC-25 in pediatric patients with hypozincemia

Kitamura Motohiro

Nobelpharma Co., Ltd.

NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo

kitamura@nobelpharma.co.jp

Kitamura Motohiro

Nobelpharma Co., Ltd.

NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo

+81-3-6670-3800

kitamura@nobelpharma.co.jp

Not Recruiting

Sept. 02, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients whose serum zinc concentrations (measured at institutions) both at the time of enrollment and within 8 weeks before enrollment are <70 micro g/dL
(2) Patients aged >=1 month and <15 years weighing <30 kg at the time of enrollment, regardless of sex and inpatient or outpatient status; however, this excludes premature babies less than 1 month of corrected age
(3) Written consent to participate in this study is obtained from a legally authorized representative and, if the patient is able to understand the content of the study, accompanying written consent or assent is obtained from the patient.

- Patients with serum albumin <80% of the institutional lower limit of normal
- Patients who have taken zinc-containing preparations or zinc-containing supplements that are prohibited from being used concomitantly within 8 weeks before enrollment

hypozincemia

NPC-25 will be administered orally.

Proportion of participants in whom the target serum zinc concentration (>=80 micro g/dL and <200 micro g/dL) is maintained for 8 weeks at the same dose by 40 weeks after the start of administration

(1) Time to first achievement of the target serum zinc concentration (>=80 micro g/dL and <200 maicro g/dL) from the start of administration
(2) Time to maintenance of the target serum zinc concentration (>=80 micro g/dL and <200 micro g/dL) for 8 weeks at the same dose from the start of administration
(3) Changes in serum zinc concentrations over time

+81-3-3881-6116

Aug. 08, 2024

No

none