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Safety and Tolerability Study of VTS-270 in Pediatric Participants With Niemann-Pick Type C (NPC) Disease

NCT03687476 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-22

No results posted yet for this study

Summary

This is a Phase-2, multicenter, multiple dose, open-label, 2-part evaluation study which will primarily assess the safety and tolerability of VTS-270 (2-hydroxypropyl beta-cyclodextrin \[HP-β-CD\]) in pediatric participants with age \<4 years.

Conditions

  • Niemann-Pick Disease, Type C

Interventions

DRUG

VTS-270

VTS-270 200 mg/mL administered as described in the arm group description.

Sponsors & Collaborators

  • Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2022-10-30
Completion
2022-10-30
FDA Drug
Yes

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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 NCT03687476 on ClinicalTrials.gov