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NCT Number: NCT00919815

Ciclosporin in the Management of New Type 1 Reactions in Leprosy

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.

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Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alert Hospital

Addis Ababa, Ethiopia

About this study

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 ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclosporin

Drug

Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Other names: Cyclosporine, Cyclosporine A

Prednisolone

Drug

prednisolone 40mg daily then reducing regimen over 24 weeks

Other names: corticosteroids

Primary outcomes

  1. improvement in nerve function and Clinical Severity Score

    Time frame: at week 4, 20, 28

Secondary outcomes

  1. Incidence of adverse events

    Time frame: up to 36 weeks

  2. Number of T1R recurrence episodes per patient in each treatment arm

    Time frame: up to 36 weeks

  3. Severity of T1R recurrence for patients in each treatment arm

    Time frame: up to 36 weeks

  4. extra prednisolone needed to control reaction

    Time frame: up to 36 weeks

  5. 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm

    Time frame: 36 weeks

  6. Mean time to recurrence of T1R for patients in each treatment arm

    Time frame: up to 36 weeks

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
  • Homes and Hospitals of St Giles

Registry information

Official study title

A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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