Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Not Applicable

Recruiting

• Conditions: Henoch-Schönlein Purpura; Mycophenolate Mofetil; Gastrointestinal Injury
• Interventions: Drug: MMF

• Registration Number: NCT05951517
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-06-19
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura	MMF	patients who were resistant to steroid were treated with MMF

Primary Outcome Measures

Name	Time	Method
Incidence of Abdominal pain, hematemesis and bloody stools	6 months	assessed by checklist

Secondary Outcome Measures

Name	Time	Method
count of red blood cells in Stool	6 months	Test for every week

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China