Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

NCT ID: NCT05951517

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Henoch-Schönlein Purpura; Gastrointestinal Injury; Mycophenolate Mofetil

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura

patients who were resistant to steroid were treated with MMF

Group Type: EXPERIMENTAL

MMF

Intervention Type: DRUG

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Interventions

MMF

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Intervention Type: DRUG

Other Intervention Names

steroid

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Weiping Tan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiping Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyan Wang, MD

Role: CONTACT

wanghy78@mail.sysu.edu.cn

+8613560489257

Facility Contacts

Haiyan Wang, MD

Role: primary

wanghy78@mail.sysu.edu.cn

8613560489257

Other Identifiers

2019-KY-021

Identifier Type: -

Identifier Source: org_study_id