Evaluating treatments for high-risk recurrence of Type 1 Autoimmune Pancreatitis
A Prospective, Randomized Controlled Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance Therapy/Glucocorticoid Combined With MMF Maintenance Therapy
This study tests if using glucocorticoids alone or with another medication can help prevent the return of Type 1 Autoimmune Pancreatitis in patients who are at high risk for it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06468709 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Type 1 AIP who exhibit high-risk characteristics for recurrence.
Not a fit: Patients with Type 2 AIP or those who do not meet the high-risk criteria for recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen to reduce the recurrence of Type 1 AIP, improving patient outcomes.
How similar studies have performed: While there have been studies on immunosuppressants for IgG4-related diseases, this specific approach for Type 1 AIP is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.