A Phase 2 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 female 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, Interventional, and Treatment
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum
Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 12 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.
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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.
standard course of prednisolone given in a reducing regimen over 16 weeks
Drug: prednisolone
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
Drug: Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Also known as: cyclosporin, Cyclosporin A
prednisolone 40mg daily then reducing regimen over 16 weeks
Also known as: corticosteroids
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
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
The record gives a start of Jul 2010, a primary completion of Dec 2012 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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 →