Trials / Unknown
UnknownNCT04189432
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
A Multicenter, Randomized, Parallel Group, Double-blind, Phase 2 Trial to Evaluate Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- SCM Lifescience Co., LTD. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response \[CR\] and partial response \[PR\] defined by National Institutes of Health \[NIH\] consensus development project criteria \[2014\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCM-CGH | SCM-CGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4). |
| OTHER | Placebo | Placebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4). |
Timeline
- Start date
- 2016-09-28
- Primary completion
- 2024-03-31
- Completion
- 2024-09-30
- First posted
- 2019-12-06
- Last updated
- 2023-06-08
Locations
11 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04189432. Inclusion in this directory is not an endorsement.