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

NCT00919451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Leprosy

Interventions

DRUG

ciclosporin

Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Sponsors & Collaborators

  • Homes and Hospitals of St Giles

    collaborator OTHER
  • Alert Hospital, Ethiopia

    collaborator OTHER
  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Diana NJ Lockwood, MBChB · London SHTM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919451 on ClinicalTrials.gov