Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 2

Conditions: Leprosy

Treatments: Drug: ciclosporin

Study type: Interventional

Funder types: Other

Identifiers

NCT00919451

ITCRBY24-T1RB

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Ciclosporin

Experimental group

Description:

ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)

Treatment:

Drug: ciclosporin