Phase 2
Completed N=48
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
Source: ClinicalTrials.gov NCT02947087 ↗Enrolled (actual)
48
Serious AEs
69.8%
Results posted
May 2023
Primary outcomePrimary: Islet Graft Function — 233; 354 ng/ml*min
Summary
Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Islet Graft Function |
233; 354 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for total pancreatectomy and islet auto-transplantation
- Age > 18 years
- Diabetes free before surgery
Exclusion Criteria
- Patients who are under immunosuppression
- Patients who have had Puestow or Frey pancreatic surgery
- Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)
Data sourced from ClinicalTrials.gov (NCT02947087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.