Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Gastrointestinal Injury Clinical Trial

Official title:

The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951517
• Other study ID #: 2019-KY-021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Haiyan Wang, MD
• Phone: +8613560489257
• Email: wanghy78[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Injury
• Henoch-Schönlein Purpura
• IgA Vasculitis
• Mycophenolate Mofetil
• Purpura

Intervention

Drug:
• MMF
MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Abdominal pain, hematemesis and bloody stools	assessed by checklist	6 months
Secondary	count of red blood cells in Stool	Test for every week	6 months