Active, not recruiting

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

This study is no longer recruiting. Please check back for study results.

WHAT IS THE PURPOSE OF THIS STUDY?

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

TRIAL AT A GLANCE

Condition

Metachromatic Leukodystrophy (MLD)

Study Intervention

Recombinant human arylsulfatase A; Recombinant human arylsulfatase A

Possibility of Active Treatment

100%

Study Type

Interventional

Phase

Phase 1/Phase 2

IS THIS STUDY RIGHT FOR ME?

AGE

0 to 13

Years

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

The study will last approximately 6 years, including follow-up visits, with the first visit occurring at Week 40 of Study HGT-MLD-070. Safety follow-up visits will be conducted by telephone 4, 12, and 24 weeks after the End of Study visit.

ENTRY CRITERIA

Has participated in study HGT-MLD-070 through Week 40

No known or suspected hypersensitivity to anesthesia or a high risk for other potential complications

Not enrolled in another clinical study that involves drugs or a drug delivery device other than Study HGT-MLD-070 within 6 months of study enrollment

No symptoms or conditions that prevent the safe use of an intrathecal device (SOPH-A-PORT Mini S)

Study Locations

    • Australia
    • Brazil
    • Czech Republic
    • Denmark
    • France
    • Germany
    • Japan

Enter your city or postal code to find a location near you.

RESULTS

  • 1.

    Kitakyushu Municipal Yahata Hospital

    Fukuoka,
    Japan

    miles

  • 2.

    Kurashiki Central Hospital

    Okayama Prefecture,
    Japan

    miles

  • 3.

    Hopital Gui de Chauliac - CHRU de Montpellier

    Montpellier,
    France

    miles

  • 4.

    Marien-Hospital Wesel gGmbh

    Wesel,
    Germany

    miles

  • 5.

    Klinikum Oldenburg

    Oldenburg,
    Germany

    miles

  • 6.

    The Children's Hospital at Westmead

    Westmead,
    Australia

    miles

  • 7.

    Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    miles

  • 8.

    Hopital Femme Mere Enfant

    Bron Cedex,
    France

    miles

  • 9.

    Rigshospitalet

    Copenhagen,
    Denmark

    miles

  • 10.

    CHU de Nantes

    Nantes Cedex 1,
    France

    miles

  • 11.

    CHR Orleans – Hopital La Source

    Orleans,
    France

    miles

  • 12.

    Center for Pediatric Clinical Studies (CPCS)

    Tubingen, Baden-Wuerttemberg
    Germany

    miles

  • 13.

    Detska Interni Klinika, Lf Mu A Fn Brno

    Brno,
    Czech Republic

    miles

  • 14.

    Hôpital de Bicêtre

    Le Kremlin Bicetre, Ile-de-France
    France

    miles

  • 15.

    Osaka University Hospital

    Osaka,
    Japan

    miles

  • 16.

    Hospital of St. Anna University

    Brno,
    Czech Republic

    miles