Completed

Has Results

Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in pediatric patients with Hunter Syndrome and Early cognitive impairment

HGTHIT094HGTHIT094 study imagejpg

WHAT IS THE PURPOSE OF THIS STUDY?

Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.

TRIAL AT A GLANCE

Condition

Hunter Syndrome

Study Intervention

idursulfase-IT; No IT treatment

Possibility of Active Treatment

66%

Study Type

Interventional

Phase

Phase 2/Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

UP TO 18

Years

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Participation will last approximately 15 months and will include visits to the study site every month for patients in the treatment group and every three months for patients in the control group.

ENTRY CRITERIA

Documented diagnosis of Hunter Syndrome (MPS II)

Has received and tolerated a minimum of 4 months of therapy with idursulfase during the period immediately prior to Screening

Displays evidence of Hunter Syndrome-related cognitive impairment

Cognitive impairment is not too advanced

No functioning CSF shunt

Study Results

Shire believes in the responsible disclosure of trial information.  We are dedicated to transparency that protects both our proprietary information and patient confidentiality while allowing access to important data.  Below please find study results for this clinical trial.

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results

Clinical Study Results
ClinicalTrials.gov Identifier
NCT02055118
Clinical Study Results
EudraCT Identifer
2013-002885-38

Study Locations

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RESULTS

  • 1.

    Hôpital Femme Mère Enfant

    Bron,
    France

    miles

  • 2.

    University of North Carolina

    Chapel Hill, NC
    United States of America

    miles

  • 3.

    Royal Manchester Children's Hospital

    Manchester, Manchester
    United Kingdom

    miles

  • 4.

    Hospital Infantil Universitario Niño Jesus

    Madrid, Madrid
    Spain

    miles

  • 5.

    Hospital Universitario Austral

    Pilar, Buenos Aires
    Argentina

    miles

  • 6.

    Instituto Nacional de Pediatría

    Coyoacan, Ciudad De México
    Mexico

    miles

  • 7.

    Children's Hospital and Research Center at Oakland

    Oakland, CA
    United States of America

    miles

  • 8.

    Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, IL
    United States of America

    miles

  • 9.

    Women's and Children's Hospital, 72 King William Road

    North Adelaide,
    Australia

    miles

  • 10.

    Fundación Cardioinfantil Instituto Cardiológico

    Bogota,
    Colombia

    miles

  • 11.

    The Hospital for Sick Children

    Toronto, ON
    Canada

    miles