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An Extension Study of NK-104 in Childhood

An Open-label, Extension and Safety Study of NK-104 in Familial Hypercholesterolemia in Childhood

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222100
Enrollment
14
Registered
2013-06-07
Start date
2013-06-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholesterolemia

Interventions

investigational material(s) Generic name etc : NK-104 INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational materi

Sponsors

Kowa Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) A subject who completed NK-104-PH-01 and is willing to receive NK-104 therapy in extension study (2) A subject who gives written assent and whose delegate gives written consent

Exclusion criteria

Exclusion criteria: (1) A subject who are not accepted to enter the trial by investigator (2) A subject who requires medication prohibited by protocol

Design outcomes

Secondary

MeasureTime frame
(1) LDL-C, TC, TG, HDL-C, Non-HDL-C, Non-HDL-C/HDL-C ratio (2) LDL-C target attainment (1) (Percent) change from baseline and value by subject (2) LDL-C target attainment by subject—

Primary

MeasureTime frame
Adverse events etc. Incidence of adverse events etc.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026