Trial · NCT02947087

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

NCT02947087, Phase 1, Phase 2, Completed, Medical University of South Carolina; results first posted 2023-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis. Trials, record NCT02947087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02947087

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
NCT number: NCT02947087
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 48 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Chronic Pancreatitis
Interventions: Prolastin-C, Placebo
First posted: 2016-10-27
Last updated: 2023-06-29
Results first posted: 2023-05-09

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Islet Graft Function	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)

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Islet Graft Function	365 days	All consented participants who received TPIAT	ng/ml*min	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Islet Graft Function	Prolastin-C		233	Standard Error 42	ng/ml*min
Islet Graft Function	Placebo		354	Standard Error 78	ng/ml*min

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prolastin-C	32
Overall Study	STARTED	Placebo	16
Overall Study	COMPLETED	Prolastin-C	29
Overall Study	COMPLETED	Placebo	14
Overall Study	NOT COMPLETED	Prolastin-C	3
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain	Gastrointestinal disorders	Prolastin-C	3	29	11
other	Abdominal Pain	Gastrointestinal disorders	Placebo	3	14	3
other	Fatigue	General disorders	Prolastin-C	2	29	3
other	Fatigue	General disorders	Placebo	0	14	0
other	Nausea and Vomitting	Gastrointestinal disorders	Prolastin-C	1	29	1
other	Nausea and Vomitting	Gastrointestinal disorders	Placebo	1	14	2
other	Hypotension	Cardiac disorders	Prolastin-C	3	29	3
other	Hypotension	Cardiac disorders	Placebo	1	14	1
other	Cellulitis	Infections and infestations	Prolastin-C	1	29	1
other	Cellulitis	Infections and infestations	Placebo	1	14	1

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prolastin-C	2	29
Total, all-cause mortality	Placebo	0	14
Total, other adverse events	Prolastin-C	15	29
Total, other adverse events	Placebo	6	14
Total, serious adverse events	Prolastin-C	22	29
Total, serious adverse events	Placebo	8	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38659255	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK105183	Alpha1 Anti-trypsin Enhances Islet Autograft Survival	WANG, HONGJUN	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2016 to 2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Prolastin-C vs Placebo: deaths from any cause	Trial comparisons
Prolastin-C vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02947087

GET https://conductscience.org/api/trials/v1/NCT02947087/events?page=2

API reference For AI assistants