# An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment

> **NCT01506141** · PHASE1,PHASE2 · COMPLETED · sponsor: **Takeda** · enrollment: 15 (actual)

## Conditions studied

- Hunter Syndrome

## Interventions

- **DRUG:** Idursulfase-IT
- **DRUG:** Elaprase

## Key facts

- **NCT ID:** NCT01506141
- **Lead sponsor:** Takeda
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-08-01
- **Primary completion:** 2024-04-30
- **Final completion:** 2024-04-30
- **Target enrollment:** 15 (ACTUAL)
- **Last updated:** 2025-08-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01506141

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01506141, "An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment". Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/clinical/NCT01506141. Licensed CC0.

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