Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

NCT03647852 | Recruiting DMC

• 1 other identifier: chfuHSP 1.0
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Henoch-Schönlein Purpura

Keywords

severe gastrointestinal involvement

Outcome Measures

Primary Outcomes (1)

• sustained abdominal pain relief

  no abdominal pain complaint and no abdominal tenderness

  3 days after treatment

Secondary Outcomes (11)

• sustained abdominal pain relief

  7 days after treatment

• other treatment rather than assigned intervention

  4 weeks after treatment

• tolarable food type

  2 weeks after treatment

• the number of days of taking fasting

  At the time of discharge

• Drug-related side effects

  3 days after treatment

Study Arms (2)

Methylprednisolone group

EXPERIMENTAL

In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)

Drug: Methylprednisolone; Drug: other basic supportive treatment

IVIG group

ACTIVE COMPARATOR

In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)

Drug: IVIG; Drug: other basic supportive treatment

Interventions

Methylprednisolone DRUG

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

Methylprednisolone group

IVIG DRUG

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

IVIG group

other basic supportive treatment DRUG

1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d

IVIG group; Methylprednisolone group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• both genders
• age between 2-16 years old
• IgA vasculitis with gastrointestinal involvement
• course of disease less than 2 months
• refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）

You may not qualify if:

• patients with severe sepsis
• patients with central nervous system infection,
• patients with severe pneumonia
• patients with chronic infection (such as EBV, CMV, Tuberculosis)
• patients complicated by CKD who need renal replacement therapy
• patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Children's Hospital: collaborator
• Shanghai Children's Medical Center: collaborator

Study Sites (3)

Children's Hospital of Fudan University

Shanghai, China

RECRUITING

Children's Hospital of Shanghai

Shanghai, China

NOT YET RECRUITING

Shanghai Children's Medical Centre

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

IgA Vasculitis

Interventions

Methylprednisolone; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Li Sun, MD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Wenyan Huang, MD

  Shanghai Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Sun, MD

CONTACT

+8618017590930; lillysun@263.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: September 1, 2019
• Primary Completion: February 27, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (3)