The Long-term Safety Study of Idursulfase-beta in Hunter... | NCT02044692

Studies
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients

NCT02044692

Sponsor

Green Cross Corporation

Status

Unknown status

Last Update Posted

Jun 20, 2014Estimated

Enrollment

34Estimated

Phase

Not provided

Conditions

Hunter Syndrome

Interventions

Not provided

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Jan 19, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 24, 2014Estimated

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

Jun 19, 2014

Last Update Posted Date

Jun 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse event and adverse drug reaction.		Once a week up to 5years

Secondary Outcomes

Measure	Description	Time Frame
Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.		Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)

Other Outcomes

Measure	Description	Time Frame
Percent change of urine GAG.		Baseline and every three months up to 5years.
Percent change of 6 minute walking test.		Baseline and every 6 months up to 5years.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.

Exclusion Criteria:

Patients who have participated in any other blind clinical trials.
Patient who cannot be tracked about safety.
Patients who are judged disqualified to participate clinical trials by investigator for other causes.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hunter Syndrome(Mucopolysaccharidosis II) Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong-Kyu Jin	Contact			jindk.jin@samsung.com

Overall Officials

Name	Affiliation	Role
Dong-Kyu Jin	Samsung medical center, Seoul, Republic of Korea	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D016532	Mucopolysaccharidosis II

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