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Safety and Efficacy of Miglustat in Chinese NPC Patients

NCT03910621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-03-30

No results posted yet for this study

Summary

This is a prospective, multi-center, open-label, non-randomized, single-arm Phase IV confirmatory study.

Approximately 19 subjects with Niemann Pick Type C disease (NPC) will be enrolled in this study. The study will be conducted at 2 sites in China.

Conditions

  • Niemann-Pick Disease, Type C

Interventions

DRUG

Miglustat

capsule, oral use

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Yue Wu · Janssen China R&D

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910621 on ClinicalTrials.gov