Skip to content

Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951517
Enrollment
24
Registered
2023-07-19
Start date
2023-01-01
Completion date
2026-12-31
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Injury, Henoch-Schönlein Purpura, Mycophenolate Mofetil

Keywords

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

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.

Interventions

DRUGMMF

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Abdominal pain, hematemesis and bloody stools6 monthsassessed by checklist

Secondary

MeasureTime frameDescription
count of red blood cells in Stool6 monthsTest for every week

Countries

China

Contacts

Primary ContactHaiyan Wang, MD
wanghy78@mail.sysu.edu.cn+8613560489257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026