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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

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

      • 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 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ciclosporin
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in nerve function
Time Frame: at 24 weeks and 32 weeks
at 24 weeks and 32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
extra prednisolone needed to control reaction
Time Frame: up to 36 weeks
up to 36 weeks
incidence of adverse effects
Time Frame: throughout 32 weeks
throughout 32 weeks
Skin lesion inflammation improvement
Time Frame: up to 36 weeks
up to 36 weeks
rate of improvement of reaction
Time Frame: up to 36 weeks
up to 36 weeks
Time to next reactional episode
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Diana NJ Lockwood, MBChB, London SHTM

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)

June 1, 2013

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 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

September 1, 2014

More Information

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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