Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

NCT05951517 | Recruiting

• 1 other identifier: 2019-KY-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Henoch-Schönlein Purpura; Gastrointestinal Injury; Mycophenolate Mofetil

Keywords

Allergic purpura; complications,; renal involvement; gastrointestinal involvement; mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

• Incidence of Abdominal pain, hematemesis and bloody stools

  assessed by checklist

  6 months

Secondary Outcomes (1)

• count of red blood cells in Stool

  6 months

Study Arms (1)

mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura

EXPERIMENTAL

patients who were resistant to steroid were treated with MMF

Drug: MMF

Interventions

MMF DRUG

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Also known as: steroid

mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages range from 3 to 18 years old;
• 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;
• Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid
• Parents or guardians agree to treatment and sign a written informed consent form.

You may not qualify if:

• Patients who are allergic to MMF;
• 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;
• Patients with other digestive system diseases;
• Those who have previously used MMF clinical trials;
• Other situations the researcher thought inappropriate to participate in the study.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

IgA Vasculitis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Weiping Tan, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Wang, MD

CONTACT

+8613560489257; wanghy78@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 19, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

CN (1)