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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02947087

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Drug: Prolastin-C Drug: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Actual Study Start Date :

Jan 11, 2017

Actual Primary Completion Date :

Nov 13, 2021

Anticipated Study Completion Date :

Nov 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prolastin-C Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.	Drug: Prolastin-C Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation Other Names: AAT
Placebo Comparator: Placebo Subjects will be given Saline weekly for 4 weeks.	Drug: Placebo Patients will receive saline on day 0, 7, 14, and 21 days of transplantation Other Names: Saline

Arm

Intervention/Treatment

Active Comparator: Prolastin-C

Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.

Drug: Prolastin-C

Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation

Other Names:

AAT

Placebo Comparator: Placebo

Subjects will be given Saline weekly for 4 weeks.

Drug: Placebo

Patients will receive saline on day 0, 7, 14, and 21 days of transplantation

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Islet graft function [365 days]
Islet graft function will be measured by mixed meal tolerance test (MMTT) at 365 days post transplantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)