Ciclosporin in the Management of New Type 1 Reactions in Leprosy

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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 with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Alert Hospital, Ethiopia; Armauer Hansen Research Institute, Ethiopia; Homes and Hospitals of St Giles
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Individuals with clinical evidence of T1R with new nerve function impairment (NFI).

• Aged 18-65

• Weigh more than 30Kg

Exclusion Criteria:

• 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