Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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 Procedure: blood purification Not Applicable

Layout table for study information
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
Estimated Study Start Date : March 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 first step fails, patients would be given IVIG(2g/kg/d)as a change
Other Name: IVIG

Procedure: blood purification
If Methylprednisolone pulse and IVIG both fail to treat, blood purification will be considered as a remedy

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
1.2g/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




Primary Outcome Measures :
  1. sustained abdominal pain relief [ Time Frame: 4 weeks after treatment ]
    no abdominal pain complaint and no abdominal tenderness


Secondary Outcome Measures :
  1. the dosage of prednisolone [ Time Frame: 4 weeks after treatment ]
    the dosage of prednisolone after tapering

  2. blood pressure [ Time Frame: 4 weeks after treatment ]
    both systolic and diastolic blood pressure will be measured

  3. 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.

  4. food type [ Time Frame: 4 weeks after treatment ]
    what kind of food can be tolerant

  5. complicated nephritis [ Time Frame: 4 weeks after treatment ]
    whether or not the patient is complicated with Henoch-Schönlein nephritis

  6. damaged organ except kidney [ Time Frame: 4 weeks after treatment ]
    whether or not the patient is complicated with damaged organ except kidney

  7. cost of treatment [ Time Frame: 4 weeks after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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
Layout table for location contacts
Contact: Li Sun, MD +8618017590930 lillysun@263.com

Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai Children's Hospital
Shanghai Children's Medical Center

Layout table for additonal information
Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03647852     History of Changes
Other Study ID Numbers: chfuHSP 1.0
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
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
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunoglobulins, Intravenous
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal