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Trial record 4 of 5 for:    "Hansen's Disease" | "Prednisolone"

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

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ClinicalTrials.gov Identifier: NCT00919451
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 25, 2015
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

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
improvement in nerve function [ Time Frame: at 24 weeks and 32 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ]
Change History Complete list of historical versions of study NCT00919451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • incidence of adverse effects [ Time Frame: throughout 24 weeks of treatment ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leprosy
Intervention  ICMJE Drug: ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Study Arms  ICMJE Experimental: Ciclosporin
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Intervention: Drug: ciclosporin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
40
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919451
Other Study ID Numbers  ICMJE ITCRBY24-T1RB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Homes and Hospitals of St Giles
  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
Investigators  ICMJE
Principal Investigator: Diana NJ Lockwood, MBChB London SHTM
PRS Account London School of Hygiene and Tropical Medicine
Verification Date September 2014

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