Ciclosporin in the Management of New Type 1 Reactions in Leprosy

March 21, 2015 updated by: Saba Lambert, London School of Hygiene and Tropical Medicine

A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Abeba, Ethiopia
        • Alert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ciclosporin arm
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Drug: Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Other Names:
  • Cyclosporine
  • Cyclosporine A
ACTIVE_COMPARATOR: prednisolone
standard course of prednisolone given in a reducing regimen over 24 weeks
Drug: Prednisolone
prednisolone 40mg daily then reducing regimen over 24 weeks
Other Names:
  • corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in nerve function and Clinical Severity Score
Time Frame: at week 4, 20, 28
at week 4, 20, 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to 36 weeks
up to 36 weeks
Number of T1R recurrence episodes per patient in each treatment arm
Time Frame: up to 36 weeks
up to 36 weeks
Severity of T1R recurrence for patients in each treatment arm
Time Frame: up to 36 weeks
up to 36 weeks
extra prednisolone needed to control reaction
Time Frame: up to 36 weeks
up to 36 weeks
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
36 weeks
Mean time to recurrence of T1R for patients in each treatment arm
Time Frame: up to 36 weeks
up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Armauer Hansen Research Institute, Ethiopia
Alert Hospital, Ethiopia
Homes and Hospitals of St Giles

Investigators

  • Principal Investigator: Diana Lockwood, MBChB, London School of Hygiene and Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (ESTIMATE)

June 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 21, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCRBY24-T1RA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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