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

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ClinicalTrials.gov Identifier: NCT02947087
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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 Name: 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 Name: Saline




Primary Outcome Measures :
  1. Islet graft function [ Time Frame: 365 days ]
    Islet graft function will be measured by mixed meal tolerance test (MMTT) at 365 days post transplantation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for total pancreactectomy and islet autotransplantation
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947087


Contacts
Contact: Ahmed Allawi 843-792-7082 allawi@musc.edu
Contact: Stefanie Owczarski 843-876-4305 owczarsm@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Ahmed Allawi    843-792-7082    allawi@musc.edu   
Contact: Stefanie Owczarski    843-876-4305    owczarsm@musc.edu   
Principal Investigator: Hongjun Wang, Ph.D         
Sub-Investigator: Katherine Morgan, M.D         
Sub-Investigator: Charlie Strange, M.D         
Sub-Investigator: David Adams, M.D         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Hongjun Wang, Ph.D Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02947087     History of Changes
Other Study ID Numbers: Pro00053906
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Medical University of South Carolina:
Islet autotransplantation
Alpha1 anti trypsin

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action