Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • MMF

    Drug

    MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpuraExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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