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Ciclosporin in the Management of New Type 1 Reactions in Leprosy

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ClinicalTrials.gov Identifier: NCT00919815
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 24, 2015
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Saba Lambert, London School of Hygiene and Tropical Medicine

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leprosy Drug: Ciclosporin Drug: Prednisolone Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: corticosteroids


Outcome Measures
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Primary Outcome Measures :
  1. improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 36 weeks ]
  2. Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ]
  3. Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ]
  4. extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]
  5. 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 ]
  6. Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919815


Locations
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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
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Principal Investigator: Diana Lockwood, MBChB London School of Hygiene and Tropical Medicine
More Information
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Responsible Party: Saba Lambert, Clinical Research Fellow, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919815     History of Changes
Other Study ID Numbers: ITCRBY24-T1RA
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Saba Lambert, London School of Hygiene and Tropical Medicine:
Leprosy
Type 1 Reactions
Prednisolone
Ciclosporin
Additional relevant MeSH terms:
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Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Cyclosporine
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Cyclosporins
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents