NCT03647852 Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
| NCT ID | NCT03647852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Henoch-Schönlein Purpura |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2026-02-27 |
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 150 participants in total. It began in 2019-09-01 with a primary completion date of 2026-02-27.
⚠ 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
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
Eligibility Criteria
Inclusion Criteria: 1. both genders 2. age between 2-16 years old 3. IgA vasculitis with gastrointestinal involvement 4. course of disease less than 2 months 5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d） Exclusion Criteria: 1. patients with severe sepsis 2. patients with central nervous system infection, 3. patients with severe pneumonia 4. patients with chronic infection (such as EBV, CMV, Tuberculosis) 5. patients complicated by CKD who need renal replacement therapy 6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
Contact & Investigator
Li Sun, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT03647852 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 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 NCT03647852 currently recruiting?
Yes, NCT03647852 is actively recruiting participants. Contact the research team at lillysun@263.com for enrollment information.
Where is the NCT03647852 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT03647852 clinical trial?
NCT03647852 is sponsored by Children's Hospital of Fudan University. The principal investigator is Li Sun, MD at Children's Hospital of Fudan University. The trial plans to enroll 150 participants.