Phase 2 N=48 Randomized Quadruple-blind Prevention

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Chronic Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT02947087 ↗

Enrolled (actual)

Serious AEs

69.8%

Results posted

May 2023

Primary outcome: Primary: Islet Graft Function — 233; 354 ng/ml*min

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Prolastin-C (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Islet Graft Function	233; 354	—

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).

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)

View full record on ClinicalTrials.gov →

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.