Status:
COMPLETED
Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Conditions:
Leprosy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment ...
Detailed Description
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosp...
Eligibility Criteria
Inclusion
- Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
- Aged 18-65
- Weigh more than 30Kg
Exclusion
- Unwillingness to give informed consent
- Patients with severe active infections such as tuberculosis
- Pregnant or breastfeeding women (see Appendix II)
- Those with renal failure, abnormal renal function, hypertensive
- Patients taking thalidomide currently or within the last 3 months
- Patients not willing to return for follow-up
- Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- HIV positive patients
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00919815
Start Date
August 1 2010
End Date
July 1 2013
Last Update
March 24 2015
Active Locations (1)
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1
Alert Hospital
Addis Ababa, Ethiopia