Ciclosporin in the Management of New 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):

Saba Lambert, London School of Hygiene and Tropical Medicine

ClinicalTrials.gov Identifier:

NCT00919815

First received: June 11, 2009

Last updated: March 21, 2015

Last verified: March 2015

History of Changes

Purpose

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	Intervention	Phase
Leprosy	Drug: Ciclosporin Drug: Prednisolone	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Cyclosporine

Genetic and Rare Diseases Information Center resources: Hansen's Disease

U.S. FDA Resources

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

Primary Outcome Measures:

improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events [ Time Frame: up to 36 weeks ] [ Designated as safety issue: Yes ]
Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]


Enrollment:	73
Study Start Date:	August 2010
Study Completion Date:	July 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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: NCT00919815

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 Lockwood, MBChB	London School of Hygiene and Tropical Medicine

More Information


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
Study First Received:	June 11, 2009
Last Updated:	March 21, 2015
Health Authority:	United Kingdom: London School of Hygiene and Tropical Medicine Ethics Committee Ethiopia: AHRI/ALERT Ethical Review Committee Ethiopia: National Science and Technology Committee of Ethiopia Ethiopia: Drug Administration and Control Authority

Keywords provided by London School of Hygiene and Tropical Medicine:


Leprosy Type 1 Reactions Prednisolone Ciclosporin

Additional relevant MeSH terms:


Leprosy Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Cyclosporins Cyclosporine Prednisolone acetate Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate 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

ClinicalTrials.gov processed this record on September 28, 2016

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