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

Chronic Pancreatitis Clinical Trial

Official title:
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02947087
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 11, 2017
Completion date November 13, 2022
View Details
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