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RecruitingNCT05951517Updated Jul 19, 2023

Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

An interventional study of MMF in Henoch-Schönlein Purpura, Gastrointestinal Injury and Mycophenolate Mofetil, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2023, registered Jun 2023).
  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Henoch-Schönlein Purpura
  • Gastrointestinal Injury
  • Mycophenolate Mofetil

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Keywords

  • Allergic purpura
  • complications,
  • renal involvement
  • gastrointestinal involvement
  • mycophenolate mofetil
03

In context

IgA Vasculitis

36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 19 interventional studies indexed under IgA Vasculitis.

Browse IgA Vasculitis studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ages range from 3 to 18 years old;
  2. 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;
  3. gastrointestinal type HSP: treated with Intravenous 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid
  4. Parents or guardians agree to treatment and sign a written form.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are allergic to MMF;
  2. Patients with severe diseases: such as systemic , heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery;
  3. Patients with other digestive system diseases;
  4. Those who have previously used MMF clinical trials;
  5. Other situations the researcher thought inappropriate to participate in the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura

    patients who were resistant to steroid were treated with MMF

    Drug: MMF

Interventions

  • DrugMMF

    MMF treat refractory gastrointestinal Henoch-Schönlein purpura

    Also known as: steroid

06

What researchers measure

Primary outcomes

  1. Incidence of Abdominal pain, hematemesis and bloody stools

    assessed by checklist

    Time frame: 6 months

Secondary outcomes

  1. count of red blood cells in Stool

    Test for every week

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05951517
Responsible party
Weiping Tan (Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jul 19, 2023
Start date
Jan 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 19, 2023

Study contacts

Haiyan Wang, MD
Contact
wanghy78@mail.sysu.edu.cn
+8613560489257
Weiping Tan, PhD
principal investigator · Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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