Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mycophenolate Mofetil; Henoch-Schönlein Purpura; Gastrointestinal Injury
• Intervention / Treatment: Drug: MMF

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyan Wang, MD; Phone Number: +8613560489257; Email: wanghy78@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Haiyan Wang, MD; Phone Number: 8613560489257; Email: wanghy78@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura; patients who were resistant to steroid were treated with MMF	Drug: MMF; MMF treat refractory gastrointestinal Henoch-Schönlein purpura; Other Names: steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Abdominal pain, hematemesis and bloody stools	assessed by checklist	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
count of red blood cells in Stool	Test for every week	6 months

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Weiping Tan, PhD, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mycophenolate mofetil; complications,; Allergic purpura; renal involvement; gastrointestinal involvement
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Hemostatic Disorders; Vasculitis; Skin Diseases, Vascular; Hypersensitivity; Blood Coagulation Disorders; Skin Manifestations; Immune Complex Diseases; Purpura; IgA Vasculitis
• Other Study ID Numbers: 2019-KY-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No