- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919451
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
March 24, 2015 updated by: London School of Hygiene and Tropical Medicine
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Addis Abeba, Ethiopia
- Alert Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ciclosporin
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
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Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement in nerve function
Time Frame: at 24 weeks and 32 weeks
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at 24 weeks and 32 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
extra prednisolone needed to control reaction
Time Frame: up to 36 weeks
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up to 36 weeks
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incidence of adverse effects
Time Frame: throughout 32 weeks
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throughout 32 weeks
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Skin lesion inflammation improvement
Time Frame: up to 36 weeks
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up to 36 weeks
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rate of improvement of reaction
Time Frame: up to 36 weeks
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up to 36 weeks
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Time to next reactional episode
Time Frame: up to 2 years
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Diana NJ Lockwood, MBChB, London SHTM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
June 11, 2009
First Submitted That Met QC Criteria
June 11, 2009
First Posted (Estimate)
June 12, 2009
Study Record Updates
Last Update Posted (Estimate)
March 25, 2015
Last Update Submitted That Met QC Criteria
March 24, 2015
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Mycobacterium Infections, Nontuberculous
- Leprosy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- ITCRBY24-T1RB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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