Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

• ClinicalTrials.gov Identifier: NCT00919451
• Recruitment Status: Completed
• First Posted: June 12, 2009
• Last Update Posted: March 25, 2015
• 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 (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: June 11, 2009
• First Posted Date: June 12, 2009
• Last Update Posted Date: March 25, 2015
• Study Start Date: August 2010
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 24, 2015): improvement in nerve function [ Time Frame: at 24 weeks and 32 weeks ]
• Original Primary Outcome Measures (submitted: June 11, 2009): improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ]
• Change History: Complete list of historical versions of study NCT00919451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: March 24, 2015)

• incidence of adverse effects [ Time Frame: throughout 32 weeks ]
• Skin lesion inflammation improvement [ Time Frame: up to 36 weeks ]
• rate of improvement of reaction [ Time Frame: up to 36 weeks ]
• Time to next reactional episode [ Time Frame: up to 2 years ]
• extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]

Original Secondary Outcome Measures (submitted: June 11, 2009)

• incidence of adverse effects [ Time Frame: throughout 24 weeks of treatment ]
• Skin lesion inflammation improvement [ Time Frame: up to 36 weeks ]
• rate of improvement of reaction [ Time Frame: up to 36 weeks ]
• Time to next reactional episode [ Time Frame: up to 2 years ]
• extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
• 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.

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leprosy

Intervention

Drug: ciclosporin

Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Study Arms

Experimental: Ciclosporin

ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)

Intervention: Drug: ciclosporin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2014): 16
• Original Estimated Enrollment (submitted: June 11, 2009): 40
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ethiopia

Administrative Information

• NCT Number: NCT00919451
• Other Study ID Numbers: ITCRBY24-T1RB
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: London School of Hygiene and Tropical Medicine
• Study Sponsor: London School of Hygiene and Tropical Medicine

Collaborators

• Homes and Hospitals of St Giles
• Alert Hospital, Ethiopia
• Armauer Hansen Research Institute, Ethiopia

Investigators

• Principal Investigator: Diana NJ Lockwood, MBChB; London SHTM

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: September 2014