Henoch-Schönlein PurpuraNCT05951517
Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
A study testing MMF in people with Henoch-Schönlein Purpura and Gastrointestinal Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Henoch-Schönlein Purpura, Gastrointestinal Injury, Mycophenolate Mofetil
- What is being tested?
- MMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Haiyan Wang, MD, 8613560489257, wanghy78@mail.sysu.edu.cn
About this study
Official title: The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
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.
Read the 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.
- Being tested
- MMF
- Keywords
- Allergic purpura, complications,, renal involvement, gastrointestinal involvement, mycophenolate mofetil
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMFDrug
Also called steroid
MMF treat refractory gastrointestinal Henoch-Schönlein purpura
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura | Experimental | patients who were resistant to steroid were treated with MMF Receives: Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Abdominal pain, hematemesis and bloody stools
assessed by checklist
Measured: 6 months
Secondary outcomes (1)
count of red blood cells in Stool
Test for every week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Henoch-Schönlein PurpuraStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiping Tan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Weiping Tan, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951517
- Sponsor's protocol ID
- 2019-KY-021
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
- ClinicalTrials.gov ID
- NCT05951517
- Acronym / sponsor ID
- 2019-KY-021
- Keywords
- Allergic purpura, complications,, renal involvement, gastrointestinal involvement, mycophenolate mofetil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura | Experimental | Drug: MMFpatients who were resistant to steroid were treated with MMF |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMFAlso: steroidMMF treat refractory gastrointestinal Henoch-Schönlein purpura | Drug | mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura |
Primary outcome
Incidence of Abdominal pain, hematemesis and bloody stools
Time frame: 6 months
assessed by checklist
1 secondary outcome
count of red blood cells in Stool
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weiping Tan, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMF in people with Henoch-Schönlein Purpura and Gastrointestinal Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Wang, MD (+8613560489257, wanghy78@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Abdominal pain, hematemesis and bloody stools (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.