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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    48
  • sponsor
    Medical University of South Carolina
Updated on 24 January 2021
diabetes
pancreatectomy
alpha-1 antitrypsin

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).

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 36514 after the transplant.

Details
Condition Chronic pancreatitis
Treatment Placebo, Prolastin-C
Clinical Study IdentifierNCT02947087
SponsorMedical University of South Carolina
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic pancreatitis?
Do you have any of these conditions: Do you have Chronic pancreatitis??
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)
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