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NCT Number: NCT05951517

Mycophenolate Mofetil in 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.

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Key information

Conditions

Henoch-Schönlein Purpura Blood Coagulation Disorders Cardiovascular Diseases Gastrointestinal Injury Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Mycophenolate Mofetil Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Haiyan Wang, MD

CONTACT

[email protected]

8613560489257

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MMF

Drug

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Other names: steroid

Primary outcomes

  1. Incidence of Abdominal pain, hematemesis and bloody stools

    Time frame: 6 months

    assessed by checklist

Secondary outcomes

  1. count of red blood cells in Stool

    Time frame: 6 months

    Test for every week

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyan Wang, MD

CONTACT

[email protected]

+8613560489257

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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