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

This study has been completed.
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919451
First received: June 11, 2009
Last updated: September 8, 2014
Last verified: September 2014

June 11, 2009
September 8, 2014
August 2010
June 2013   (final data collection date for primary outcome measure)
improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919451 on ClinicalTrials.gov Archive Site
  • 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
Allocation: Non-Randomized
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.
 
Completed
16
July 2013
June 2013   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00919451
ITCRBY24-T1RB
Yes
London School of Hygiene and Tropical Medicine
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
September 2014

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