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

Primary Purpose

Chronic Pancreatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prolastin-C
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pancreatitis focused on measuring Islet autotransplantation, Alpha1 anti trypsin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prolastin-C

Placebo

Arm Description

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

Subjects will be given Saline weekly for 4 weeks.

Outcomes

Primary Outcome Measures

Islet Graft Function
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)

Secondary Outcome Measures

Full Information

First Posted
October 18, 2016
Last Updated
June 16, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02947087
Brief Title
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
Official Title
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
November 13, 2021 (Actual)
Study Completion Date
November 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
Islet autotransplantation, Alpha1 anti trypsin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolastin-C
Arm Type
Active Comparator
Arm Description
Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be given Saline weekly for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Prolastin-C
Other Intervention Name(s)
AAT
Intervention Description
Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
Primary Outcome Measure Information:
Title
Islet Graft Function
Description
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)
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongjun Wang, Ph.D
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified dataset available for sharing with researchers
IPD Sharing Time Frame
Available 01MAR2023 indefinitely
IPD Sharing Access Criteria
email to Wangho@musc.edu

Learn more about this trial

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

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