Ciclosporin in the Management of New Type 1 Reactions in Leprosy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by London School of Hygiene and Tropical Medicine. Recruitment status was Not yet recruiting

First Received on June 11, 2009. No Changes Posted

Sponsor:	London School of Hygiene and Tropical Medicine
Collaborators:	Homes and Hospitals of St Giles Alert Hospital, Ethiopia Armauer Hansen Research Institute, Ethiopia
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00919815

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 II Phase III

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 Depo-medrol Cyclosporine Medrol veriderm Cyclosporin Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2009

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)
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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919815

Contacts

Contact: Saba M Lambert, MBChB	+447921266473	saba.lambert@lshtm.ac.uk
Contact: Diana Lockwood, MBChB	+44 20 7927 2457	diana.lockwood@lshtm.ac.uk

Locations

Ethiopia
Alert Hospital	Not yet recruiting
Addis Abeba, Ethiopia
Contact: Saba Lambert saba.lambert@lshtm.ac.uk
Principal Investigator: Diana J Lockwood, MBChB
Principal Investigator: Saba M Lambert, MBChB
Principal Investigator: Elisabeth Bizuneh, MD
Principal Investigator: Wim Brandsma
Sub-Investigator: Fasil Tesfaye, MD
Sub-Investigator: Ahmed Bedru, MD
Sub-Investigator: Jemal Hussein, MD
Sub-Investigator: Lawrence Yamuah

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

No publications provided

Responsible Party:	Professor Diana Lockwood, 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:	June 11, 2009
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
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone 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
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012