CompletedPhase 3

A Study of GC1111 in Hunter Syndrom Patients

South Korea32 participantsStarted 2017-03-09

Plain-language summary

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

Who can participate

Age range5 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in 6-MWT

Timeframe: at Week 53 from baseline

Trial details

NCT IDNCT03920540

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-15

View on ClinicalTrials.gov More Hunter Syndrome trials