Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
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.
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 25, 2015
September 1, 2014
2.8 years
June 11, 2009
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement in nerve function
at 24 weeks and 32 weeks
Secondary Outcomes (5)
incidence of adverse effects
throughout 32 weeks
Skin lesion inflammation improvement
up to 36 weeks
rate of improvement of reaction
up to 36 weeks
Time to next reactional episode
up to 2 years
extra prednisolone needed to control reaction
up to 36 weeks
Study Arms (1)
Ciclosporin
EXPERIMENTALciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Interventions
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Eligibility Criteria
You may qualify if:
- Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
- Aged 18-65
- Weigh more than 30Kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Homes and Hospitals of St Gilescollaborator
- Alert Hospital, Ethiopiacollaborator
- Armauer Hansen Research Institute, Ethiopiacollaborator
Study Sites (1)
Alert Hospital
Addis Ababa, Ethiopia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana NJ Lockwood, MBChB
London SHTM
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
August 1, 2010
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
March 25, 2015
Record last verified: 2014-09