MedTrace Logo

Study of Idursulfase-beta (GC1111) in Hunter Syndrome

NCT02663024 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-01-26

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.

Conditions

  • Mucopolysaccharidosis II

Interventions

BIOLOGICAL

idursulfase beta

IV, weekly infusion for 24 weeks

BIOLOGICAL

idursulfase

0.5 mg/kg, iv, weekly infusion for 24 weeks

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-12-31
Completion
2020-06-30

More Related Trials

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 NCT02663024 on ClinicalTrials.gov