Evalution the Safety and Efficacy in Atopic Dermatitis Pa... | NCT03962387

Studies
Evalution the Safety and Efficacy in Atopic Dermatitis Patients

NCT03962387

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 16, 2021Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Not applicable(observational study)

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2019Actual

Primary Completion Date

Jan 2, 2024Estimated

Completion Date

Jan 2, 2024Estimated

First Submitted Date

Nov 28, 2018

First Submission Date that Met QC Criteria

May 21, 2019

First Posted Date

May 24, 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

Jun 15, 2021

Last Update Posted Date

Jun 16, 2021Actual

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

Description Module

Brief Summary

A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

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

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atopic Dermatitis			Other: Not applicable(observational study)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable(observational study)	Other	Not applicable(observational study)	Atopic Dermatitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)		5 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)		3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who enrolled K0102 Clinical Trial(parent study).
Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

In case follow-up is not possible from end of K0102 clinical trial to end of this study period
Any other condition which the investigator judges would make patient unsuitable for study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

moderate to severe chronic atopic dermatitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea, Seoul ST. Mary's Hospital		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
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided