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Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Primary Purpose

Leprosy

Status
Completed
Phase
Phase 2
Locations
Ethiopia
Study Type
Interventional
Intervention
Ciclosporin
Prednisolone
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leprosy focused on measuring Leprosy, Type 1 Reactions, Prednisolone, Ciclosporin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ciclosporin arm

prednisolone

Arm Description

ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)

standard course of prednisolone given in a reducing regimen over 24 weeks

Outcomes

Primary Outcome Measures

improvement in nerve function and Clinical Severity Score

Secondary Outcome Measures

Incidence of adverse events
Number of T1R recurrence episodes per patient in each treatment arm
Severity of T1R recurrence for patients in each treatment arm
extra prednisolone needed to control reaction
6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm
Mean time to recurrence of T1R for patients in each treatment arm

Full Information

First Posted
June 11, 2009
Last Updated
March 21, 2015
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT00919815
Brief Title
Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Official Title
A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy
Keywords
Leprosy, Type 1 Reactions, Prednisolone, Ciclosporin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ciclosporin arm
Arm Type
Experimental
Arm Description
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Arm Title
prednisolone
Arm Type
Active Comparator
Arm Description
standard course of prednisolone given in a reducing regimen over 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ciclosporin
Other Intervention Name(s)
Cyclosporine, Cyclosporine A
Intervention Description
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
corticosteroids
Intervention Description
prednisolone 40mg daily then reducing regimen over 24 weeks
Primary Outcome Measure Information:
Title
improvement in nerve function and Clinical Severity Score
Time Frame
at week 4, 20, 28
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
up to 36 weeks
Title
Number of T1R recurrence episodes per patient in each treatment arm
Time Frame
up to 36 weeks
Title
Severity of T1R recurrence for patients in each treatment arm
Time Frame
up to 36 weeks
Title
extra prednisolone needed to control reaction
Time Frame
up to 36 weeks
Title
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
Title
Mean time to recurrence of T1R for patients in each treatment arm
Time Frame
up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Lockwood, MBChB
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alert Hospital
City
Addis Abeba
Country
Ethiopia

12. IPD Sharing Statement

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Ciclosporin in the Management of New Type 1 Reactions in Leprosy

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