A Phase 2/3 interventional study of Ciclosporin and Prednisolone in Leprosy, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Ethiopia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 2/3, Interventional, and Treatment
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.
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 73 is close to the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Drug: Ciclosporin
standard course of prednisolone given in a reducing regimen over 24 weeks
Drug: Prednisolone
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Also known as: Cyclosporine, Cyclosporine A
prednisolone 40mg daily then reducing regimen over 24 weeks
Also known as: corticosteroids
improvement in nerve function and Clinical Severity Score
Time frame: at week 4, 20, 28
Incidence of adverse events
Time frame: up to 36 weeks
Number of T1R recurrence episodes per patient in each treatment arm
Time frame: up to 36 weeks
Severity of T1R recurrence for patients in each treatment arm
Time frame: up to 36 weeks
extra prednisolone needed to control reaction
Time frame: up to 36 weeks
6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm
Time frame: 36 weeks
Mean time to recurrence of T1R for patients in each treatment arm
Time frame: up to 36 weeks
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclosporine
London School of Hygiene and Tropical Medicine →