A Study of GC1111 in Hunter Syndrom Patients

Phase 3CompletedNCT03920540

Green Cross Corporation32 enrolled

Overview

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hunter Syndrome

Interventions

GC1111COMBINATION_PRODUCT

GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

ComparatorCOMBINATION_PRODUCT

Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

Eligibility

Sex: MALEMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with Hunter syndrome * Male at the age of ≥ 5 * Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator. * Voluntarily signed written informed consent to participation in this study * Consent to contraception Exclusion Criteria: * Prior treatment with iduronate-2-sulfatase ERT * History of bronchotomy, bone marrow trasplanation, or cord blood transplanation. * Known hypersensitivity reactions to any of the components of the invetigational product * Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study. * Unable to perform 6-MWT. * Female

Locations (1)

Samsug Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Change in 6-MWT

Time frame: at Week 53 from baseline

Data from ClinicalTrials.gov

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