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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
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:
NCT00919815
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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:


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
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

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
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on November 27, 2014