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Register:	ClinicalTrials.gov
Last refreshed on:	22 May 2023
Main ID:	NCT02947087
Date of registration:	18/10/2016
Prospective Registration:	Yes
Primary sponsor:	Medical University of South Carolina
Public title:	Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
Scientific title:	Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival
Date of first enrolment:	January 11, 2017
Target sample size:	48
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02947087
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 1/Phase 2

Countries of recruitment
United States

Contacts

Name:	Hongjun Wang, Ph.D
Address:
Telephone:
Email:
Affiliation:	Medical University of South Carolina

Key inclusion & exclusion criteria

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)

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Drug: Placebo

Drug: Prolastin-C

Primary Outcome(s)

Islet Graft Function [Time Frame: 365 days]

Secondary Outcome(s)

Secondary ID(s)

5R01DK105183

Pro00053906

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Ethics review

Results

Results available:	Yes
Date Posted:	09/05/2023
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02947087

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