Back to resultsAlpha-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
About this trial
This is an interventional prevention trial for Chronic Pancreatitis focused on measuring Islet autotransplantation, Alpha1 anti trypsin
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)
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
NCT ID
NCT02947087
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)
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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