Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
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| ClinicalTrials.gov Identifier: NCT03647852 |
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Recruitment Status :
Recruiting
First Posted : August 27, 2018
Last Update Posted : January 10, 2022
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Sponsor:
Children's Hospital of Fudan University
Collaborators:
Shanghai Children's Hospital
Shanghai Children's Medical Center
Information provided by (Responsible Party):
Children's Hospital of Fudan University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Henoch-Schönlein Purpura | Drug: Methylprednisolone Drug: IVIG Drug: other basic supportive treatment | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | October 30, 2022 |
| Estimated Study Completion Date : | October 30, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Abdominal Pain
| Arm | Intervention/treatment |
|---|---|
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Experimental: Methylprednisolone group
In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
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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
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Active Comparator: IVIG group
In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
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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 Drug: other basic supportive treatment
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Primary Outcome Measures :
- sustained abdominal pain relief [ Time Frame: 3 days after treatment ]no abdominal pain complaint and no abdominal tenderness
Secondary Outcome Measures :
- sustained abdominal pain relief [ Time Frame: 7 days after treatment ]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
- other treatment rather than assigned intervention [ Time Frame: 4 weeks after treatment ]other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
- tolarable food type [ Time Frame: 2 weeks after treatment ]what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
- the number of days of taking fasting [ Time Frame: At the time of discharge ]the number of days of taking fasting will be counted at the time of discharge
- Drug-related side effects [ Time Frame: 3 days after treatment ]Side effects associated with methylprednisolone and IVIG will be recorded
- hypertension [ Time Frame: 7 days after treatment ]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.
- infection [ Time Frame: 4 weeks after treatment ]different infection types should be specified
- ocular hypertension [ Time Frame: 7 days after treatment ]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
- steroid-related diabetes [ Time Frame: 3 days after treatment ]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
- cost of treatment [ Time Frame: 4 weeks after treatment ]cost of treatment will be obtained from discharge fee list
- The number of days in hospital [ Time Frame: at the time of discharge ]The number of days in hospital will be counted at the time of discharge
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| Ages Eligible for Study: | 2 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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）
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647852
Contacts
| Contact: Li Sun, MD | +8618017590930 | lillysun@263.com |
Locations
| China | |
| Children's Hospital of Fudan University | Recruiting |
| Shanghai, China | |
| Contact: Li Sun, MD | |
| Children's Hospital of Shanghai | Not yet recruiting |
| Shanghai, China | |
| Contact: Wenyan Huang, MD | |
| Shanghai Children's Medical Centre | Not yet recruiting |
| Shanghai, China | |
| Contact: Wei Zhou, MD | |
Sponsors and Collaborators
Children's Hospital of Fudan University
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 |
| Responsible Party: | Children's Hospital of Fudan University |
| ClinicalTrials.gov Identifier: | NCT03647852 |
| Other Study ID Numbers: |
chfuHSP 1.0 |
| First Posted: | August 27, 2018 Key Record Dates |
| Last Update Posted: | January 10, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Children's Hospital of Fudan University:
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severe gastrointestinal involvement |
Additional relevant MeSH terms:
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Purpura, Schoenlein-Henoch Purpura Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Vasculitis Vascular Diseases Cardiovascular Diseases Hemostatic Disorders Hemorrhagic Disorders Immune Complex Diseases Hypersensitivity Immune System Diseases |
Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |