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Completed

NCT Number: NCT00919451

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

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.

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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

Primary location

Alert Hospital

Addis Ababa, Ethiopia

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 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

Treatment and study plan

Ciclosporin

Drug

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

Primary outcomes

  1. improvement in nerve function

    Time frame: at 24 weeks and 32 weeks

Secondary outcomes

  1. incidence of adverse effects

    Time frame: throughout 32 weeks

  2. Skin lesion inflammation improvement

    Time frame: up to 36 weeks

  3. rate of improvement of reaction

    Time frame: up to 36 weeks

  4. Time to next reactional episode

    Time frame: up to 2 years

  5. extra prednisolone needed to control reaction

    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 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.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Mar 25, 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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