Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
NCT00919451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2015-03-25
Summary
Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy
Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.
Conditions
- Leprosy
Interventions
- DRUG
-
ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Sponsors & Collaborators
-
Homes and Hospitals of St Giles
collaborator OTHER -
Alert Hospital, Ethiopia
collaborator OTHER -
Armauer Hansen Research Institute, Ethiopia
collaborator OTHER -
London School of Hygiene and Tropical Medicine
lead OTHER
Principal Investigators
-
Diana NJ Lockwood, MBChB · London SHTM
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-07-31
Countries
- Ethiopia
Study Locations
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