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

This study has been completed.
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919451
First received: June 11, 2009
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Leprosy
Drug: ciclosporin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of adverse effects [ Time Frame: throughout 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Skin lesion inflammation improvement [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • rate of improvement of reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Time to next reactional episode [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciclosporin
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919451

Locations
Ethiopia
Alert Hospital
Addis Abeba, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Investigators
Principal Investigator: Diana NJ Lockwood, MBChB London SHTM
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919451     History of Changes
Other Study ID Numbers: ITCRBY24-T1RB
Study First Received: June 11, 2009
Last Updated: September 8, 2014
Health Authority: Ethiopia: Ethical Review Committee
Ethiopia: Ethiopia Science and Technology Commission
Ethiopia: Drug Administration and Control Authority

Keywords provided by London School of Hygiene and Tropical Medicine:
Leprosy
Type 1 Reaction
Prednisolone
Ciclosporin

Additional relevant MeSH terms:
Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Cyclosporins
Cyclosporine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014