hypozincemia
Conditions
Interventions
NPC-25 will be administered orally.
Sponsors
Kitamura Motohiro
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients whose serum zinc concentrations (measured at institutions) both at the time of enrollment and within 8 weeks before enrollment are =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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Time to first achievement of the target serum zinc concentration (>=80 micro g/dL and =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 | — |
Contacts
Public ContactMotohiro Kitamura
Nobelpharma Co., Ltd.
Outcome results
None listed