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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: ciclosporin
    • Ciclosporin 7.5mg/kg – reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Arms, Groups and Cohorts

  • Experimental: Ciclosporin
    • ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)

Clinical Trial Outcome Measures

Primary Measures

  • improvement in nerve function
    • Time Frame: at 24 weeks and 32 weeks

Secondary Measures

  • incidence of adverse effects
    • Time Frame: throughout 32 weeks
  • Skin lesion inflammation improvement
    • Time Frame: up to 36 weeks
  • rate of improvement of reaction
    • Time Frame: up to 36 weeks
  • Time to next reactional episode
    • Time Frame: up to 2 years
  • extra prednisolone needed to control reaction
    • Time Frame: up to 36 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • London School of Hygiene and Tropical Medicine
  • Collaborator
    • Homes and Hospitals of St Giles
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Diana NJ Lockwood, MBChB, Principal Investigator, London SHTM

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