Evaluating treatments for high-risk recurrence of Type 1 Autoimmune Pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the recurrence-free survival rate in patients with Type 1 Autoimmune Pancreatitis (AIP) who are at high risk for recurrence. The study compares the effectiveness of glucocorticoids alone versus a combination of glucocorticoids and mycophenolate mofetil (MMF). Participants will be monitored for signs of recurrence and the safety of the treatments will be assessed. The trial aims to establish a consensus on reducing recurrence rates in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent form with date;
2. Promise to comply with research procedures and cooperate with the implementation of the entire process research;
3. Age 18 and above, regardless of gender;
4. Confirmed as type I AIP and high-risk for recurrence, including the following characteristics: IgG4\>4 times the upper limit of normal value before treatment; The serum IgG4 level remained high after GC treatment; Pancreatic diffuse enlargement; IgG4-SC with proximal bile duct involvement; Involvement of extrapancreatic organs;
5. Indications for treatment, (1) symptomatic individuals may experience pancreatic involvement (such as obstructive jaundice, abdominal pain, lower back pain, etc.) and extrapancreatic organ involvement (such as jaundice caused by bile duct stenosis, etc.); (2) Asymptomatic individuals, who may develop subclinical AIP (persistent pancreatic mass, liver dysfunction with proximal IgG4 associated sclerosing cholangitis) with severe and irreversible damage to important organs;
6. Able to persist and cooperate with research interventions, such as oral medication;
7. If it is a woman in the reproductive period, contraception should be used for at least one month before screening, and a commitment should be made to use contraception throughout the entire study period and continue until the specified time after the end of the study

Exclusion Criteria:

1. Pregnant/lactating women; Inability or refusal to sign informed consent form;
2. History of mental illness;
3. Allergy to research interventions;
4. With malignant tumors;
5. Active hepatitis/tuberculosis and other infectious diseases;
6. With underlying diseases that are difficult to control, such as severe heart failure, respiratory failure, etc;
7. Within 3 months, use of glucocorticoids or immunosuppressants due to other illnesses

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Duowu Zou, Doctor — Ruijin Hospital
• Study coordinator: XIaonan Shen, Doctor
• Email: hgssldsxn@163.com
• Phone: 18817554263

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inebilizumab for Type 1 Autoimmune Pancreatitis in Adults

  This study tests whether inebilizumab can help adults with type 1 autoimmune pancreatitis by reducing relapses when paired with a standardized steroid taper.

  Recruiting Phase 4 Ruijin Hospital · Shanghai · NCT07862075

• Identifying genes that affect Acute Intermittent Porphyria

  This study is trying to find out which genes might make people more likely to have attacks of Acute Intermittent Porphyria or help protect them from it, and it's for anyone aged 12 and older who has symptoms or is related to someone with the condition.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT05502133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.