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

Primary Purpose

Leprosy

Status
Completed
Phase
Phase 2
Locations
Ethiopia
Study Type
Interventional
Intervention
ciclosporin
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 Reaction, Prednisolone, Ciclosporin

Eligibility Criteria

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

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

Sites / Locations

  • Alert Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ciclosporin

Arm Description

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

Outcomes

Primary Outcome Measures

improvement in nerve function

Secondary Outcome Measures

incidence of adverse effects
Skin lesion inflammation improvement
rate of improvement of reaction
Time to next reactional episode
extra prednisolone needed to control reaction

Full Information

First Posted
June 11, 2009
Last Updated
March 24, 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
NCT00919451
Brief Title
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciclosporin
Arm Type
Experimental
Arm Description
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Intervention Type
Drug
Intervention Name(s)
ciclosporin
Intervention Description
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Primary Outcome Measure Information:
Title
improvement in nerve function
Time Frame
at 24 weeks and 32 weeks
Secondary Outcome Measure Information:
Title
incidence of adverse effects
Time Frame
throughout 32 weeks
Title
Skin lesion inflammation improvement
Time Frame
up to 36 weeks
Title
rate of improvement of reaction
Time Frame
up to 36 weeks
Title
Time to next reactional episode
Time Frame
up to 2 years
Title
extra prednisolone needed to control reaction
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana NJ Lockwood, MBChB
Organizational Affiliation
London SHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alert Hospital
City
Addis Abeba
Country
Ethiopia

12. IPD Sharing Statement

Learn more about this trial

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

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