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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919451
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 11, 2009
June 11, 2009
August 2009
Not Provided
improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • incidence of adverse effects [ Time Frame: throughout 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Skin lesion inflammation improvement [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • rate of improvement of reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Time to next reactional episode [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
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 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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leprosy
Drug: ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Experimental: Ciclosporin
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Intervention: Drug: ciclosporin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
Not Provided
Not Provided

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
Both
18 Years to 65 Years
No
Contact: Saba M Lambert, MBChB +447921266473 saba.lambert@lshtm.ac.uk
Contact: Diana NJ Lockwood, MBChB +44 20 7927 2457 diana.lockwood@lshtm.ac.uk
Ethiopia
 
NCT00919451
ITCRBY24-T1RB
Yes
Professor Diana Lockwood, London SHTM
London School of Hygiene and Tropical Medicine
  • Homes and Hospitals of St Giles
  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
Principal Investigator: Diana NJ Lockwood, MBChB London SHTM
London School of Hygiene and Tropical Medicine
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP