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Clinical Trials in China / NCT05951517
Recruiting Not applicable

Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

NCT05951517 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Not applicable
Started
2023-01-01
Last updated
2023-07-19

Condition(s) studied

Henoch-Schönlein PurpuraGastrointestinal InjuryMycophenolate Mofetil

Investigational drug(s) / intervention(s)

MMF

MMF: MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Study summary

Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of \~10/100,000, whereas \>90% of the patients develop symptoms at \<10 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Ages range from 3 to 18 years old; 2. 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; 3. Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid 4. Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: 1. Patients who are allergic to MMF; 2. 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; 3. Patients with other digestive system diseases; 4. Those who have previously used MMF clinical trials; 5. Other situations the researcher thought inappropriate to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05951517 on ClinicalTrials.gov ↗ ← All trials in China