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Serine Protease Inhibitor

Anti-Inflammatory Therapy for Chronic Pancreatitis

Phase 4
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-68 years
Scheduled for total pancreatectomy and IAT at University of Minnesota (UM) after review by a multi-disciplinary committee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 year
Awards & highlights

Study Summary

This trial will study whether two anti-inflammatory therapies can reduce damage to transplanted islets and improve long-term outcomes for patients with severe chronic pancreatitis who have had their pancreas removed and their islets transplanted into the liver.

Who is the study for?
Adults aged 18-68 with severe chronic pancreatitis, scheduled for a pancreas removal and islet transplant at the University of Minnesota, can join. They must be able to consent and not have conditions like IgA deficiency, HIV, hepatitis B/C, TB, certain blood disorders or use medications affecting glucose tolerance. Pregnant women or those planning pregnancy are excluded.Check my eligibility
What is being tested?
The trial tests if anti-inflammatory drugs etanercept or alpha-1 antitrypsin improve outcomes after total pancreatectomy with islet autotransplant (TPIAT). Participants will either receive one of these drugs or standard care post-surgery and will be monitored for up to two years.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs tested (etanercept/A1AT), increased risk of infections due to immune system suppression by these therapies, potential worsening of demyelinating diseases with etanercept use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 68 years old.
Select...
I am approved for a complete pancreas removal and islet auto-transplant at UM.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal acute C-peptide response to glucose (ACRmax)
Secondary outcome measures
ACRmax
AUC glucose
Severe Adverse Events
+5 more

Side effects data

From 2013 Phase 4 trial • 210 Patients • NCT01313208
12%
Injection site erythema
11%
Rheumatoid arthritis
8%
Injection site rash
8%
Sinusitis
8%
Upper respiratory tract infection
8%
Headache
7%
Injection site pruritus
7%
Bronchitis
7%
Urinary tract infection
6%
Nasopharyngitis
6%
Arthralgia
6%
Pain in extremity
6%
Rash
6%
Fatigue
5%
Injection site pain
5%
Back pain
5%
Nausea
1%
Transient ischaemic attack
1%
Anaemia
1%
Supraventricular tachycardia
1%
Menorrhagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etanercept-Etanercept
Placebo-Etanercept

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: etanerceptExperimental Treatment1 Intervention
Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept.
Group II: alpha-1 antitrypsinExperimental Treatment1 Intervention
Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP)
Group III: Standard CareActive Control1 Intervention
Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
etanercept
2005
Completed Phase 4
~15620
Alpha 1-Antitrypsin
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,367 Previous Clinical Trials
1,587,465 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,155 Total Patients Enrolled

Media Library

Alpha 1-Antitrypsin (Serine Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02713997 — Phase 4
Pancreatitis, Diabetes Research Study Groups: Standard Care, etanercept, alpha-1 antitrypsin
Pancreatitis, Diabetes Clinical Trial 2023: Alpha 1-Antitrypsin Highlights & Side Effects. Trial Name: NCT02713997 — Phase 4
Alpha 1-Antitrypsin (Serine Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02713997 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial permit participants of greater than fifty-five years old?

"The parameters for participation in this clinical trial stipulate that patients must be between 18 and 65 years old. There are 12 studies recruiting those younger than 18, as well as 109 trials targeting seniors over the age of 65."

Answered by AI

What are the ramifications of utilizing etanercept therapeutically?

"We rate etanercept's safety score as a 3, owing to its successful passage of clinical trials and official approval."

Answered by AI

Who would generally be considered to be suitable participants for this investigation?

"This clinical trial is recruiting 44 individuals of legal age (18-65) with a diagnosis of chronic pancreatitis for total pancreatectomy and IAT at the University of Minnesota. A multi-disciplinary team comprised of surgeons, gastroenterologists specialized in pancreatic diseases, pain specialists, psychologists, and endocrinologists are responsible for confirming the patient's suitability to participate in this study."

Answered by AI

Are participants being accepted into this research project presently?

"Unfortunately, this clinical trial has ceased patient recruitment. It was initially posted on December 1st 2016 and last updated on August 12th 2022. However, if interested in other trials related to pancreatitis or etanercept there are currently 82 and 38 studies respectively that remain open for participant enrollment."

Answered by AI

What is the aggregate of participants enrolled in this clinical experiment?

"At this moment, applications are not being accepted for this trial. The original posting was on the 1st of December 2016 and there has been a recent update on August 12th 2022. If you want to explore other studies, right now 82 clinical trials related to pancreatitis chronicity and 38 etanercept-based studies are actively seeking participants."

Answered by AI

What other research initiatives have been conducted utilizing etanercept?

"Currently, 38 scientific investigations into etanercept are underway with 13 of those programs in their final phase. The majority of these trials take place around Xi'an, Shaanxi however there is a global network of 745 sites running such studies."

Answered by AI

In what medical circumstances is etanercept typically utilized?

"Etanercept is capable of alleviating moderate to severe symptoms caused by alpha 1-antitrypsin deficiency and other diseases."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Mar 2025