NCT06468709 A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence
| NCT ID | NCT06468709 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ruijin Hospital |
| Condition | Type 1 AIP |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 86 participants in total. It began in 2024-06-20 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Autoimmune pancreatitis (AIP) is an autoimmune disease with low incidence rate and involving the pancreas. In China, type I AIP is predominant. Glucocorticoids (GC) have a significant therapeutic effect. Even though a consensus has been reached on the effective initial GC treatment dose, type I AIP is prone to recurrence after GC induction and maintenance therapy. Currently, there is no consensus on how to reduce the disease recurrence rate in high-risk type I AIP patients. Multiple studies have shown that immunosuppressants (IM) combined with GC can effectively reduce the disease recurrence rate in IgG4 RD patients, including azathioprine, mycophenolate mofetil (MMF), etc. Among them, the incidence of adverse reactions in MMF is relatively low. As a special type of IgG4-RD, there is currently no prospective study evaluating the efficacy and safety of GC combined with MMF treatment in high-risk recurrent type I AIP patients. The smooth implementation of this project can provide new treatment ideas and evidence-based medicine for reducing the recurrence rate of high-risk type I AIP.
Eligibility 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
Contact & Investigator
Duowu Zou, Doctor
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06468709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 AIP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06468709 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06468709 currently recruiting?
Yes, NCT06468709 is actively recruiting participants. Contact the research team at hgssldsxn@163.com for enrollment information.
Where is the NCT06468709 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06468709 clinical trial?
NCT06468709 is sponsored by Ruijin Hospital. The principal investigator is Duowu Zou, Doctor at Ruijin Hospital. The trial plans to enroll 86 participants.