[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"henoch-schnlein-purpura\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:henoch-schnlein-purpura":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100281139","phase-2-a-randomized-multicenter-study-for-isolated-skin-vasculitis-100281139",false,"NCT02939573","A Randomized Multicenter Study for Isolated Skin Vasculitis","ARAMIS","Inclusion Criteria:\n\n1. Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. Eligible patients will have a diagnosis of either:\n\n   * Isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis or cutaneous polyarteritis nodosa (PAN)\n   * IgA vasculitis (IgA, formerly Henoch-Schönlein purpura), without active and\u002For progressing renal involvement (stable glomerular filtration rate (GFR) \\>60 ml\u002Fmin; absence of, or mild-and-stable microscopic hematuria without red blood cell casts; absence of, or mild-and-stable proteinuria (\\\u003C1g\u002F24 hours); not requiring systemic immunosuppressive therapy).\n\n   These conditions, when skin-limited, are all currently treated in similar manners in practice. Mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia (Hb ≥ 10 g\u002FdL) will be allowed.\n2. The diagnosis of vasculitis must have been confirmed by skin biopsy prior to enrollment (earlier, at diagnosis, and\u002For just prior to enrollment) that has included an immunofluorescence study (in the case of small vessel vasculitis).\n3. Patients must have active cutaneous vasculitis lasting for at least 1 month continuously and\u002For have had 2 or more flares over the six months preceding enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).\n4. Patients must have active \u002F ongoing cutaneous vasculitis lesions at the time of enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).\n5. Patients may have a contra-indication to one of the study drug or have been treated prior to enrollment with one of the study medications but failed to respond to it (according to the study definitions of failure and if they have been on the drug at the target dose or higher for 3 months or longer) or had to stop it because of an adverse event. Such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of such patients enrolled directly in stage 2 will be capped at 10 (10% of the total recruitment target).\n6. Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment. For the patients on prednisone at the time of enrollment, prednisone should be stopped within a maximum of 6 weeks after enrollment and initiation of the study drug, following a pre-defined tapering schedule. Patients on long-term, low and stable dose of glucocorticoids (≤5 mg\u002Fday prednisone-equivalent) for other conditions (e.g., asthma or adrenal insufficiency) can be enrolled if the likelihood of requiring a dose increase for this other condition is low during the 6 month study period (these patients will remain on that low and stable dose during the study period, with the option to receive one short course of prednisone at higher doses for skin vasculitis flare during the first 3 months of the study period, like any other patients enrolled).\n7. Participant age 18 years or greater.\n\nExclusion Criteria:\n\n1. Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. The presence of mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia \\[Hb ≥ 10 g\u002FdL\\] are not exclusion criteria. Mild and stable microscopic hematuria without RBC casts and\u002For mild and stable proteinuria (\\\u003C1g\u002F24 hours) are not exclusion criteria. These latter patients must not require systemic immunosuppressive therapy because of possible renal involvement and their GFR must be \\>60 ml\u002Fmin.\n2. Known systemic and\u002For non-skin-isolated vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, central nervous system vasculitis and patients with detectable antineutrophil cytoplasmic antibody (ANCA) by immunofluorescence or ELISA.\n3. Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides such as those secondary to systemic lupus erythematosus, Sjögren syndrome, another auto-immune condition, a cancer, a hematological disorder, an ongoing active infection, or an ongoing medication. Investigators should consider such underlying diagnoses and perform and interpret appropriate laboratory work-up where indicated based on clinical presentation.\n4. History of significant intolerance, allergy or serious adverse events to any of the study medications: such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).\n5. Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse events.\n6. Deficit in glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (all patients must be tested for G6PD at the screening visit to assess for their eligibility): such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (azathioprine or colchicine). The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).\n7. Low or absent thiopurine methyltransferase (TPMT) activity (if known, not a requirement for study entry): Patients known to have low or absent TPMT can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (dapsone or colchicine).\n8. Evidence of significant hepatic insufficiency or liver function tests \\> 2 times the upper limit of normal.\n9. Evidence of significant renal insufficiency or creatinine clearance \\\u003C 60 mL\u002Fmin.\n10. Evidence of significant or symptomatic anemia or Hb \\\u003C 10 g\u002FdL.\n11. Comorbid condition that has moderate or high likelihood of requiring intermittent courses of prednisone within the study period, according to the investigator (e.g. chronic obstructive pulmonary disease (COPD), unstable or severe asthma).\n12. Active cancer or history of malignancy within the previous 5 years (patient in remission of a cancer \\>5 years, or with non-metastatic prostate cancer or treated basal or squamous cell carcinoma of the skin can be enrolled).\n13. Active uncontrolled or serious infection that may compromise or contra-indicate the use of the study medications.\n14. Patient unable to consent.\n15. Pregnant or lactating women.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.",[26,27,28,29],"Primary Cutaneous Vasculitis","Cutaneous Polyarteritis Nodosa","IgA Vasculitis","Henoch-Schönlein Purpura","RECRUITING","2026-01-21",{"date":33,"type":34},"2026-01-23","ACTUAL",{"date":36,"type":34},"2017-01-01",{"date":38,"type":20},"2028-12-31",{"name":40,"class":41},"University of Pennsylvania","OTHER",16,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":5},"100335471","clinical-study-on-strategy-for-refractory-henoch-schnlein-purpura-100335471","NCT03647852","Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura","Inclusion Criteria:\n\n1. both genders\n2. age between 2-16 years old\n3. IgA vasculitis with gastrointestinal involvement\n4. course of disease less than 2 months\n5. refractory to ordinary dosage of prednisolone (less than 2mg\u002Fkg\u002Fd）\n\nExclusion Criteria:\n\n1. patients with severe sepsis\n2. patients with central nervous system infection,\n3. patients with severe pneumonia\n4. patients with chronic infection (such as EBV, CMV, Tuberculosis)\n5. patients complicated by CKD who need renal replacement therapy\n6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy","2 Years","16 Years",{"count":52,"type":20},150,[54],"NA","IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.",[29],[58],"severe gastrointestinal involvement","2025-02-18",{"date":61,"type":34},"2025-02-19",{"date":63,"type":34},"2019-09-01",{"date":65,"type":20},"2026-10-30",{"name":67,"class":41},"Children's Hospital of Fudan University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":17,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100512366","mycophenolate-mofetil-in-gastrointestinal-henoch-schonlein-purpura-100512366","NCT05951517","Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura","The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura","Inclusion Criteria:\n\n1. Ages range from 3 to 18 years old;\n2. Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination;\n3. Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg\u002Fkg\u002Fd for 3 days without effecacy or relapsed during the attenuation of corticosteroid\n4. Parents or guardians agree to treatment and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients who are allergic to MMF;\n2. Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery;\n3. Patients with other digestive system diseases;\n4. Those who have previously used MMF clinical trials;\n5. Other situations the researcher thought inappropriate to participate in the study.","3 Years",{"count":77,"type":20},24,[54],"Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of \\~10\u002F100,000, whereas \\>90% of the patients develop symptoms at \\\u003C10 years of age. Although HSP is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. The management of HSP includes symptomatic treatment and immunosuppressive therapy in certain patients. Previous retrospective studies have reported that most patients with gastrointestinal (GI) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of HSP patients with GI did not achieved remission after administering of steroid. Therefore, the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.",[29,81,82],"Gastrointestinal Injury","Mycophenolate Mofetil",[84,85,86,87,88],"Allergic purpura","complications,","renal involvement","gastrointestinal involvement","mycophenolate mofetil","2023-07-18",{"date":91,"type":34},"2023-07-19",{"date":93,"type":34},"2023-01-01",{"date":95,"type":20},"2026-12-31",{"name":97,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",1,"Henoch Schönlein Purpura"]