A Study of GC1111 in Hunter Syndrom Patients | NCT03920540

Studies
A Study of GC1111 in Hunter Syndrom Patients

NCT03920540

Sponsor

Green Cross Corporation

Status

Completed

Last Update Posted

Apr 16, 2024Actual

Enrollment

32Actual

Phase

Phase 3

Conditions

Hunter Syndrome

Interventions

GC1111
Comparator

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2017Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Feb 15, 2022Actual

First Submitted Date

Apr 16, 2019

First Submission Date that Met QC Criteria

Apr 16, 2019

First Posted Date

Apr 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2024

Last Update Posted Date

Apr 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GC1111	Experimental	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.	Combination Product: GC1111
Comparator (Part 1)	Active Comparator	In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks.	Combination Product: Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GC1111	Combination Product	GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.	GC1111

Measure	Description	Time Frame
Change in 6-MWT		at Week 53 from baseline

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DongKyu Jin, M.D., Ph.D.	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsug Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016532	Mucopolysaccharidosis II
D013398	Sudden Infant Death

Ancestor Terms

ID	Term
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided