Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

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.

Study Overview

• Status: Recruiting
• Conditions: Henoch-Schönlein Purpura
• Intervention / Treatment: Drug: Methylprednisolone; Drug: other basic supportive treatment; Drug: IVIG

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Sun, MD; Phone Number: +8618017590930; Email: lillysun@263.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Children's Hospital of Fudan University
    • Contact: Li Sun, MD
  • Shanghai, China
    • Not yet recruiting
    • Children's Hospital of Shanghai
    • Contact: Wenyan Huang, MD
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Children's Medical Centre
    • Contact: Wei Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methylprednisolone group; In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)	Drug: 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; Drug: other basic supportive treatment; Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day; Low molecular weight heparin calcium 50IU/kg.d
Active Comparator: IVIG group; In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)	Drug: other basic supportive treatment; Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day; Low molecular weight heparin calcium 50IU/kg.d; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sustained abdominal pain relief	no abdominal pain complaint and no abdominal tenderness	3 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sustained abdominal pain relief	3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment	7 days after treatment
other treatment rather than assigned intervention	other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed	4 weeks after treatment
tolarable food type	what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )	2 weeks after treatment
the number of days of taking fasting	the number of days of taking fasting will be counted at the time of discharge	At the time of discharge
Drug-related side effects	Side effects associated with methylprednisolone and IVIG will be recorded	3 days after treatment
hypertension	systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.	7 days after treatment
infection	different infection types should be specified	4 weeks after treatment
ocular hypertension	1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg	7 days after treatment
steroid-related diabetes	1. with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l	3 days after treatment
cost of treatment	cost of treatment will be obtained from discharge fee list	4 weeks after treatment
The number of days in hospital	The number of days in hospital will be counted at the time of discharge	at the time of discharge

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Shanghai Children's Hospital; Shanghai Children's Medical Center
• Investigators: Principal Investigator: Li Sun, MD, Children's Hospital of Fudan University; Principal Investigator: Wenyan Huang, MD, Shanghai Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: severe gastrointestinal involvement
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Hemostatic Disorders; Vasculitis; Skin Diseases, Vascular; Hypersensitivity; Blood Coagulation Disorders; Skin Manifestations; Immune Complex Diseases; Purpura; IgA Vasculitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: chfuHSP 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No