Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
1 other identifier
observational
24
1 country
7
Brief Summary
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2015
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedSeptember 6, 2017
September 1, 2016
5.9 years
November 11, 2015
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all kinds of adverse events which occur during the clinical sutdy
Safety outcome
114 weeks
Secondary Outcomes (2)
ratio of patients who is applicable to CDAI<150
114 weeks
ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
114 weeks
Interventions
Eligibility Criteria
Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.
You may qualify if:
- patients who has history of FURESTEM-CD Inj. injection at least once.
- patients who understand and voluntarily sign an informed consent form.
You may not qualify if:
- any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Seoul National Universtiy Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Soeul National University Hospital
Soeul, 110-7441, South Korea
The Catholic University of Korea, St. Vincent'S Hospital.
Suwon, 16247, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suk-kyun Yang
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
October 6, 2016
Study Start
November 1, 2015
Primary Completion
October 1, 2021
Study Completion
November 1, 2021
Last Updated
September 6, 2017
Record last verified: 2016-09