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Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

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ClinicalTrials.gov Identifier: NCT03647852
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
Shanghai Children's Hospital
Shanghai Children's Medical Center
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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

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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, 2021
Estimated Study Completion Date : October 30, 2021


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




Primary Outcome Measures :
  1. sustained abdominal pain relief [ Time Frame: 3 days after treatment ]
    no abdominal pain complaint and no abdominal tenderness


Secondary Outcome Measures :
  1. 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

  2. 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

  3. tolarable food type [ Time Frame: 2 weeks after treatment ]
    what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )

  4. 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

  5. Drug-related side effects [ Time Frame: 3 days after treatment ]
    Side effects associated with methylprednisolone and IVIG will be recorded

  6. 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.

  7. infection [ Time Frame: 4 weeks after treatment ]
    different infection types should be specified

  8. 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

  9. 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

  10. cost of treatment [ Time Frame: 4 weeks after treatment ]
    cost of treatment will be obtained from discharge fee list

  11. 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:

  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

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
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Contact: Li Sun, MD +8618017590930 lillysun@263.com

Locations
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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
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Principal Investigator: Li Sun, MD Children's Hospital of Fudan University
Principal Investigator: Wenyan Huang, MD Shanghai Children's Hospital
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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: November 13, 2019
Last Verified: November 2019
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

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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:
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
Signs and Symptoms
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