Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Research of Standard Diagnosis and Treatment for Severe HSP in Children

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: NCT02540720
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Aihua Zhang, Nanjing Children's Hospital

Brief Summary:
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Drug: Dexamethasone Drug: Gamma globulin Procedure: Hemoperfusion Phase 2

Detailed Description:

Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.

In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.

The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group 1
Dexamethasone 0.5mg/kg.d i.v.
Drug: Dexamethasone
Experimental: group 2
Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg
Drug: Dexamethasone
Drug: Gamma globulin
Experimental: group 3
Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days
Drug: Dexamethasone
Procedure: Hemoperfusion



Primary Outcome Measures :
  1. The Symptoms of Digestive Tract [ Time Frame: 2 weeks ]
    The stomachache and other symptoms of digestive tract disappear

  2. The Symptoms of Joint System [ Time Frame: 2 weeks ]
    The arthralgia disappears


Secondary Outcome Measures :
  1. The Skin Rash [ Time Frame: 2 weeks ]
    The Skin Rash disappears

  2. Renal function [ Time Frame: 2 weeks ]
    There is no damage in kidney.



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:

  • Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days

Exclusion Criteria:

  • The children with congenital diseases

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): NCT02540720


Contacts
Layout table for location contacts
Contact: Aihua Zhang, M.D. +8618951769017 bszah@163.com
Contact: Yimei Wu +8615951757930 wym891203@163.com

Locations
Layout table for location information
China, Jiangsu
Nanjing Children's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Aihua Zhang, M.D.    +8618951769017    bszah@163.com   
Sponsors and Collaborators
Nanjing Children's Hospital
Investigators
Layout table for investigator information
Study Chair: Aihua Zhang, M.D. Department of Nephrology, Nanjing children's hospital

Layout table for additonal information
Responsible Party: Aihua Zhang, Hospital vice president, Nanjing Children's Hospital
ClinicalTrials.gov Identifier: NCT02540720     History of Changes
Other Study ID Numbers: Zhai
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
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
Dexamethasone
Dexamethasone acetate
BB 1101
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones