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A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India

NCT05058391 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-01-23

Study results available
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Summary

The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome.

Participants will receive Elaprase once per week over a 3-hour period which can be reduced to 1 hour as determined by the study doctor. Participants will need to visit the clinic weekly during the duration of the study.

Conditions

Interventions

BIOLOGICAL

Elaprase

Elaprase IV infusion.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2024-04-06
Completion
2024-04-18

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058391 on ClinicalTrials.gov