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

Phase 1

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Drug: Placebo; Drug: Prolastin-C

• Registration Number: NCT02947087
• Lead Sponsor: Medical University of South Carolina

Brief 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).

Detailed Description

The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. This is a prospective, controlled, double-blind study. The primary endpoint will be area under the curve for the serum C-peptide level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2017-01-11
• Primary Completion: 2021-11-13
• Study Completion: 2022-11-13
• Results First Submitted: 2023-01-26
• Results First Submitted QC: 2023-05-08
• Results First Posted: 2023-05-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will be given Saline weekly for 4 weeks.
Prolastin-C	Prolastin-C	Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Islet Graft Function	365 days	Islet graft function will be measured by 4 hour mixed meal tolerance test (MMTT) at 365 days post transplantation. Specific measurement is the C-peptide area under the curve (AUC)

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States