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An Efficacy and Safety Study of HGT-1110 in Participants With Metachromatic Leukodystrophy

NCT01887938 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-21

No results posted yet for this study

Summary

The purpose of this study is to collect long-term safety data in participants with metachromatic leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070 (NCT01510028) through Week 40.

Conditions

  • Metachromatic Leukodystrophy (MLD)

Interventions

BIOLOGICAL

HGT-1110

Participants will receive IT injection of HGT-1110.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-23
Primary Completion
2026-02-13
Completion
2026-02-13

Countries

  • Australia
  • Brazil
  • Czechia
  • Denmark
  • France
  • Germany
  • Japan

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 NCT01887938 on ClinicalTrials.gov