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

NCT02947087 | Completed Phase 1 Results DMC

• 2 other identifiers: Pro000539065R01DK105183
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pancreatitis

Keywords

Islet autotransplantation; Alpha1 anti trypsin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prolastin-C

ACTIVE COMPARATOR

Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.

Drug: Prolastin-C

Placebo

PLACEBO COMPARATOR

Subjects will be given Saline weekly for 4 weeks.

Drug: Placebo

Interventions

Prolastin-C DRUG

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

Also known as: AAT

Prolastin-C

Placebo DRUG

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for total pancreatectomy and islet auto-transplantation
• Age \> 18 years
• Diabetes free before surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; alpha 1-Antitrypsin Deficiency

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Hongjun Wang, PhD
• Organization: MUSouthCarolina

wangho@musc.edu

8437921800

Study Officials

• Hongjun Wang, Ph.D

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 27, 2016
• Study Start: January 11, 2017
• Primary Completion: November 13, 2021
• Study Completion: November 13, 2022
• Last Updated: June 29, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available 01MAR2023 indefinitely
• Access Criteria: email to Wangho@musc.edu

Locations

US (1)