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OpenTrials
Completed

NCT Number: NCT02947087

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

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).

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Subcutaneous Emphysema alpha 1-Antitrypsin Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prolastin-C

Drug

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

Other names: AAT

Placebo

Drug

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

Other names: Saline

Primary outcomes

  1. Islet Graft Function

    Time frame: 365 days

    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)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 27, 2016
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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