NCT02926300
Unknown
N/A
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
Kang Stem Biotech Co., Ltd.7 sites in 1 country24 target enrollmentNovember 2015
ConditionsCrohn's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- Kang Stem Biotech Co., Ltd.
- Enrollment
- 24
- Locations
- 7
- Primary Endpoint
- all kinds of adverse events which occur during the clinical sutdy
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients who has history of FURESTEM-CD Inj. injection at least once.
- •patients who understand and voluntarily sign an informed consent form.
Exclusion Criteria
- •any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
Outcomes
Primary Outcomes
all kinds of adverse events which occur during the clinical sutdy
Time Frame: 114 weeks
Safety outcome
Secondary Outcomes
- ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)(114 weeks)
- ratio of patients who is applicable to CDAI<150(114 weeks)
Study Sites (7)
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