NCT02947087

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

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	Prolastin-C	Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation
DRUG	Placebo	Patients will receive saline on day 0, 7, 14, and 21 days of transplantation

Timeline

• Start date: 2017-01-11
• Primary completion: 2021-11-13
• Completion: 2022-11-13
• First posted: 2016-10-27
• Last updated: 2023-06-29
• Results posted: 2023-05-09

Locations

1 site across 1 country: United States