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Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

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ClinicalTrials.gov Identifier: NCT03647852
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : February 22, 2019
Sponsor:
Collaborators:
Shanghai Children's Hospital
Shanghai Children's Medical Center
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date February 22, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
sustained abdominal pain relief [ Time Frame: 4 weeks after treatment ]
no abdominal pain complaint and no abdominal tenderness
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03647852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • the dosage of prednisolone [ Time Frame: 4 weeks after treatment ]
    the dosage of prednisolone after tapering
  • blood pressure [ Time Frame: 4 weeks after treatment ]
    both systolic and diastolic blood pressure will be measured
  • infection [ Time Frame: 6 month after treatment ]
    The patient will be followed to 6 months after treatment and he will pay visit to the doctor every four weeks and will be evaluated for health condition. At 6 month the frequency of infection and the type of infection will be summarized.
  • food type [ Time Frame: 4 weeks after treatment ]
    what kind of food can be tolerant
  • complicated nephritis [ Time Frame: 4 weeks after treatment ]
    whether or not the patient is complicated with Henoch-Schönlein nephritis
  • damaged organ except kidney [ Time Frame: 4 weeks after treatment ]
    whether or not the patient is complicated with damaged organ except kidney
  • cost of treatment [ Time Frame: 4 weeks after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Official Title  ICMJE Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Henoch-Schönlein Purpura
Intervention  ICMJE
  • Drug: Methylprednisolone
    1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the first step fails, patients would be given IVIG(2g/kg/d)as a change
    Other Name: IVIG
  • Drug: IVIG
    1.2g/kg and oral prednisolone 2mg/kg/d 2.if the first step fails, patients would be given methylprednisolone (15-30mg/kg/d)for 3 days as a change
    Other Name: Methylprednisolone
  • Procedure: blood purification
    If Methylprednisolone pulse and IVIG both fail to treat, blood purification will be considered as a remedy
Study Arms  ICMJE
  • Experimental: Methylprednisolone group
    In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
    Interventions:
    • Drug: Methylprednisolone
    • Procedure: blood purification
  • Active Comparator: IVIG group
    In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
    Interventions:
    • Drug: IVIG
    • Procedure: blood purification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 5mg/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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li Sun, MD +8618017590930 lillysun@263.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03647852
Other Study ID Numbers  ICMJE chfuHSP 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE
  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center
Investigators  ICMJE Not Provided
PRS Account Children's Hospital of Fudan University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP