An interventional study of Leflunomide in Henoch-Schonlein Purpura, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
This study conducted a prospective, multicenter, one-arm clinical trial on the combination of leflunomide and steroid therapy for refractory skin Henoch-Schonlein Purpura in children on the basis of ethical principles. A one-year follow-up was conducted to evaluate the changes in the main indicators (frequency of rash recurrence) and secondary indicators (proportion of kidney damage, proportion of joint involvement, T lymphocyte subpopulations, and inflammatory factors) before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of refractory skin type HSP in children, it is expected that leflunomide combined with conventional treatment can improve the remission rate of HSP children's skin purpura and reduce HSP recurrence. The research results are expected to bring new treatment methods and strategies for this group of patients.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or new rash still appears, and it frequently repeats more than 3 times during hospitalization.
Drug: Leflunomide
When patients appeared with rashes and treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rashes do not subside or fresh rash still appears, and it frequently repeats more than 3 times during hospitalization. Leflunomide would be administered
Rash frequency
Rash frequency in a months
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2027, 53 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Leflunomide
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →