Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Henoch-Schönlein Purpura Clinical Trial

Official title:

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647852
• Other study ID #: chfuHSP 1.0
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 30, 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Li Sun, MD
• Phone: +8618017590930
• Email: lillysun[@]263.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Henoch-Schönlein Purpura
• IgA Vasculitis
• Purpura

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai
China	Children's Hospital of Shanghai	Shanghai
China	Shanghai Children's Medical Centre	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Shanghai Children's Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained abdominal pain relief	no abdominal pain complaint and no abdominal tenderness	3 days after treatment
Secondary	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
Secondary	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
Secondary	tolarable food type	what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )	2 weeks after treatment
Secondary	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
Secondary	Drug-related side effects	Side effects associated with methylprednisolone and IVIG will be recorded	3 days after treatment
Secondary	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
Secondary	infection	different infection types should be specified	4 weeks after treatment
Secondary	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
Secondary	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
Secondary	cost of treatment	cost of treatment will be obtained from discharge fee list	4 weeks after treatment
Secondary	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