NCT05951517 Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
| NCT ID | NCT05951517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Henoch-Schönlein Purpura |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Weiping Tan, PhD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT05951517 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Henoch-Schönlein Purpura. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05951517 currently recruiting?
Yes, NCT05951517 is actively recruiting participants. Contact the research team at wanghy78@mail.sysu.edu.cn for enrollment information.
Where is the NCT05951517 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05951517 clinical trial?
NCT05951517 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Weiping Tan, PhD at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 24 participants.