CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Prolastin-C +1 moredrug
Likely dose
Prolastin-C 60mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02947087
NCT02947087Phase 2Completed
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Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Medical University of South Carolina·interventional·Posted Oct 27, 2016·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Prolastin-C and Placebo for Chronic Pancreatitis. Completed, enrolled 48 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pancreatitis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 27, 2016
Enrollment StartJan 11, 2017
Primary CompletionNov 13, 2021
Study CompletionNov 13, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.7 years ago

Interventions

Prolastin-Cdrug

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

Placebodrug

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