A Study of GC1111 in Hunter Syndrom Patients

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Hunter Syndrome

Treatments: Combination Product: Comparator; Combination Product: GC1111

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920540

GC1111_P3

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

GC1111

Experimental group

Description:

In part 1, all participants who randomized into GC1111 arm should receive the GC1111 for 52 weeks. In part 2, all enrolled participants should receive the GC1111 for 52 weeks.

Treatment:

Combination Product: GC1111

Comparator (Part 1)

Active Comparator group

Description:

In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks.

Treatment:

Combination Product: Comparator