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

Chronic Pancreatitis Clinical Trial

Official title:

Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947087
• Other study ID #: Pro00053906
• Secondary ID: 5R01DK105183
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 11, 2017
• Est. completion date: November 13, 2022

Study information

• Verified date: June 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 365±14 after the transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 13, 2022
• Est. primary completion date: November 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	365 days