A Phase 2 interventional study of prednisolone and ciclosporin 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 2015-03-26.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 2, Interventional, and Treatment
Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.
Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 20 is below 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 16 weeks (additional prednisolone given for the first four weeks)
Drug: ciclosporin
standard course of prednisolone given in a reducing regimen over 16 weeks
Drug: prednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks
Also known as: corticosteroids
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Also known as: Cyclosporine, Cyclosporin A
number of ENL recurrence episodes per patient
Time frame: up to 32 weeks
Mean time to ENL recurrence after initial control
Time frame: up to 32 weeks
Severity of ENL at recurrence
Time frame: up to 32 weeks
Amount of additional prednisolone required by patients
Time frame: up to 32 weeks
Frequency of adverse events for patients in each treatment arm
Time frame: up to 32 weeks
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Time frame: up to 32 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 →