Back to resultsMycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
Primary Purpose
Henoch-Schönlein Purpura, Gastrointestinal Injury, Mycophenolate Mofetil
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MMF
Sponsored by
About this trial
This is an interventional treatment trial for Henoch-Schönlein Purpura focused on measuring Allergic purpura, complications,, renal involvement, gastrointestinal involvement, mycophenolate mofetil
Eligibility Criteria
Inclusion Criteria: Ages range from 3 to 18 years old; Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination; Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Patients who are allergic to MMF; Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery; Patients with other digestive system diseases; Those who have previously used MMF clinical trials; Other situations the researcher thought inappropriate to participate in the study.
Sites / Locations
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura
Arm Description
patients who were resistant to steroid were treated with MMF
Outcomes
Primary Outcome Measures
Incidence of Abdominal pain, hematemesis and bloody stools
assessed by checklist
Secondary Outcome Measures
count of red blood cells in Stool
Test for every week
Full Information
NCT ID
NCT05951517
First Posted
June 19, 2023
Last Updated
July 18, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05951517
Brief Title
Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
Official Title
The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of ~10/100,000, whereas >90% of the patients develop symptoms at <10 years of age. Although HSP is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. The management of HSP includes symptomatic treatment and immunosuppressive therapy in certain patients. Previous retrospective studies have reported that most patients with gastrointestinal (GI) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of HSP patients with GI did not achieved remission after administering of steroid. Therefore, the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.
Detailed Description
the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Henoch-Schönlein Purpura, Gastrointestinal Injury, Mycophenolate Mofetil
Keywords
Allergic purpura, complications,, renal involvement, gastrointestinal involvement, mycophenolate mofetil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura
Arm Type
Experimental
Arm Description
patients who were resistant to steroid were treated with MMF
Intervention Type
Drug
Intervention Name(s)
MMF
Other Intervention Name(s)
steroid
Intervention Description
MMF treat refractory gastrointestinal Henoch-Schönlein purpura
Primary Outcome Measure Information:
Title
Incidence of Abdominal pain, hematemesis and bloody stools
Description
assessed by checklist
Time Frame
6 months
Secondary Outcome Measure Information:
Title
count of red blood cells in Stool
Description
Test for every week
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages range from 3 to 18 years old;
Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination;
Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid
Parents or guardians agree to treatment and sign a written informed consent form.
Exclusion Criteria:
Patients who are allergic to MMF;
Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery;
Patients with other digestive system diseases;
Those who have previously used MMF clinical trials;
Other situations the researcher thought inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Wang, MD
Phone
+8613560489257
Email
wanghy78@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Tan, PhD
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Wang, MD
Phone
8613560489257
Email
wanghy78@mail.sysu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
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