Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

NCT ID: NCT03647852

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2026-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylprednisolone group

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

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: 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

other basic supportive treatment

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

IVIG

Intervention Type: 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

other basic supportive treatment

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Children's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Wenyan Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Hospital

Locations

Children's Hospital of Fudan University

Shanghai, , China

Site Status: RECRUITING

Children's Hospital of Shanghai

Shanghai, , China

Site Status: NOT_YET_RECRUITING

Shanghai Children's Medical Centre

Shanghai, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Li Sun, MD

Role: CONTACT

lillysun@263.com

+8618017590930

Facility Contacts

Li Sun, MD

Role: primary

Wenyan Huang, MD

Role: primary

Wei Zhou, MD

Role: primary

Other Identifiers

chfuHSP 1.0

Identifier Type: -

Identifier Source: org_study_id