An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease
NCT02123966 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2018-07-24
Summary
This research study is evaluating the effectiveness of topical sirolimus combined with topical steroid therapy, as a possible treatment for oral cGVHD.
Conditions
- Chronic Graft-versus-Host-Disease
- Oral Mucosal Disease Due to Graft-versus-host Disease
Interventions
- DRUG
-
Sirolimus
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Nathaniel S Treister, DMD, DMSc · Brigham and Women's Hospital
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 4 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2016-05-31
- Completion
- 2016-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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