NCT02412787 - Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 14, 2015

Primary Completion Date

April 18, 2024

Study Completion Date

April 18, 2024

Conditions

Hunter Syndrome

Interventions

DRUG

Idursulfase-IT

Participants received 10 mg of idursulfase-IT intrathecally via IDDD or LP once every 28 days. Participants who were younger than 3 years of age received an adjusted dose of 7.5 mg (\>8 months to 30 months of age) and 10 mg (\>30 months to 3 years of age).

DRUG

Elaprase

Participants received intravenous (IV) Elaprase infusions at a minimum of 48 hours after IT administration of idursulfase-IT.

Trial Locations (9)

5006

Women's and Children's Hospital, Adelaide

27514

University of North Carolina, Chapel Hill

28009

Hospital Infantil Universitario Niño Jesus, Madrid

60611

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago

69677

Hôpital Femme Mère Enfants, Bron

94609

Children's Hospital and Research Center at Oakland, Oakland

M5G 1X8

The Hospital for Sick Children, Toronto

04530

Instituto Nacional de Pediatría, Coyoacán

M13 9WL

Royal Manchester Children's Hospital, Manchester