Actively Recruiting
The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Sch f6nlein Purpura
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-07-19
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Henoch Sch f6nlein purpura (HSP) is the most common vasculitis in children, mostly affecting those under 10 years old. While HSP usually resolves on its own, it can cause serious complications like intestinal blockage or kidney failure. This study focuses on children with refractory gastrointestinal HSP, meaning their digestive symptoms did not improve after steroid treatment, to better understand their clinical features and assess the effects of mycophenolate mofetil (MMF) in these cases. The study treats patients who have not responded to steroids with the drug mycophenolate mofetil (MMF). MMF is given to children aged 3 to 18 who have gastrointestinal HSP that is resistant to steroid therapy. This treatment is evaluated in an interventional study without masking or placebo comparison. Patients receive MMF after being identified as steroid-resistant. During the 6-month study period, researchers monitor the incidence of abdominal pain, vomiting blood, and bloody stools as primary outcomes. They also measure red blood cell counts in stool samples as a secondary outcome. Participants are assessed regularly to track symptom changes and treatment effects. The total participation time and follow-up ensure safety and evaluate the clinical outcome of MMF in refractory gastrointestinal HSP cases.
CONDITIONS
Brief Title
Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages range from 3 to 18 years old
- Diagnosed with Henoch-Sch�f6nlein purpura involving the digestive tract, showing acute abdominal colic, intussusception, or gastrointestinal bleeding
- Refractory gastrointestinal HSP: no improvement or relapse after intravenous corticosteroid treatment at 2 mg/kg/day for 3 days
- Parent or guardian agrees and signs informed consent
You will not qualify if you...
- Allergy to mycophenolate mofetil (MMF)
- Severe diseases such as systemic malignancies, heart failure, liver or renal failure, immune deficiency, severe infection, organ transplant, or emergency surgery indications
- Other digestive system diseases
- Previous participation in MMF clinical trials
- Other reasons deemed inappropriate by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who are resistant to steroid treatment receive mycophenolate mofetil (MMF) for refractory gastrointestinal Henoch-Schönlein purpura.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
H
Haiyan Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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