Status:
COMPLETED
Ciclosporin in the Management of Steroid Resistant 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
Brief 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 w...
Eligibility Criteria
Inclusion
- Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00919451
Start Date
August 1 2010
End Date
July 1 2013
Last Update
March 25 2015
Active Locations (1)
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1
Alert Hospital
Addis Ababa, Ethiopia