# A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®

> **NCT00920647** · PHASE1,PHASE2 · COMPLETED · sponsor: **Shire** · enrollment: 16 (actual)

## Conditions studied

- Hunter Syndrome

## Interventions

- **OTHER:** Control
- **DRUG:** Idursulfase IT (1 mg)
- **DRUG:** Idursulfase IT (10 mg)
- **DRUG:** Idursulfase IT (30 mg)

## Key facts

- **NCT ID:** NCT00920647
- **Lead sponsor:** Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-11-18
- **Primary completion:** 2012-10-29
- **Final completion:** 2012-10-29
- **Target enrollment:** 16 (ACTUAL)
- **Last updated:** 2021-06-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00920647

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00920647, "A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00920647. Licensed CC0.

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