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A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence

Study acronym: AIP；MMF
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 6 months later Mar 31, 2027 → Sep 30, 2029
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Ruijin Hospital

Record History

  1. Primary completion pushed from Mar 31, 2027 to Sep 30, 2029 Primary endpoint(s) modified · Completion pushed from Jul 31, 2027 to Sep 30, 2029 · Start date changed from estimate of Jun 20, 2024 to Jun 30, 2024 · 5 more Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Jul 31, 2027 to Sep 30, 2029
    • Start date changed from estimate of Jun 20, 2024 to Jun 30, 2024
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 87 words
    • Collaborators expanded, about 74 words
    • Study title shortened, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ruijin Hospital
370 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT06468709
Lead Sponsor Ruijin Hospital
Collaborators: First Hospital of China Medical University, Tianjin Medical University General Hospital, Zunyi Medical College, The First People's Hospital of Yunnan, Anhui Provincial Hospital, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
Conditions Type 1 AIP
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov