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Clinical trial

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

ID
Name
chfuHSP 1.0
Description
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.
Trial arms
Trial start
2019-09-01
Estimated PCD
2024-10-30
Trial end
2025-10-30
Status
Recruiting
Treatment
Methylprednisolone
1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
Arms:
Methylprednisolone group
IVIG
1. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
Arms:
IVIG group
other basic supportive treatment
1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d
Arms:
IVIG group, Methylprednisolone group
Size
150
Primary endpoint
sustained abdominal pain relief
3 days after treatment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-02-07

1 organization

2 products

1 drug

1 indication

Organization
Children's Hospital of Fudan University
Product
Methylprednisolone
Indication
Henoch-Schönlein Purpura
Drug
IVIG
Product
Other Basic Supportive Treatment