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An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)

NCT07344376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-15

No results posted yet for this study

Summary

The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients who received Hunterase for more than 6 months

Conditions

Interventions

DRUG

Hunterase

0.5mg/kg weekly IV administration

Sponsors & Collaborators

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

    collaborator UNKNOWN

  • GC Biopharma Corp

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT07344376 on ClinicalTrials.gov