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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2022-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anti-inflammatory Therapy to Improve Outcomes After TPIAT

NCT02713997

Pancreatitis, Chronic; Diabetes; Transplant

COMPLETED PHASE4

Analysis of Graft Function Following Autologous Islet Transplantation

NCT03097185

Chronic Pancreatitis

RECRUITING

Aralast NP in Islet Transplant

NCT02520076

Type 1 Diabetes Mellitus

COMPLETED PHASE1/PHASE2

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

NCT05664880

Chronic Pancreatitis

RECRUITING EARLY_PHASE1

Effect of Acetyl-L-carnitine on Chronic Pancreatitis

NCT02538146

Chronic Pancreatitis

TERMINATED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prolastin-C

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

Group Type ACTIVE_COMPARATOR

Prolastin-C

Intervention Type DRUG

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

Placebo

Subjects will be given Saline weekly for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prolastin-C

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AAT Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No