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Ciclosporin in the Management of Steroid Resistant 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
Sponsor:
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:
NCT00919451
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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: 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:

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

Estimated Enrollment: 40
Study Start Date: August 2009
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919451

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

Locations
Ethiopia
Alert Hospital Not yet recruiting
Addis Abeba, Ethiopia
Contact: Saba M Lambert, MBChB     +447921266473     saba.lambert@lshtm.ac.uk    
Contact: Diana NJ Lockwood, MBChB     +44 20 7927 2457     diana.lockwood@lshtm.ac.uk    
Principal Investigator: Diana NJ 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, MBChB            
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 NJ Lockwood, MBChB London SHTM
  More Information

No publications provided

Responsible Party: Professor Diana Lockwood, London SHTM
ClinicalTrials.gov Identifier: NCT00919451     History of Changes
Other Study ID Numbers: ITCRBY24-T1RB
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 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 May 21, 2013