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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
Must not have
Pre-existing diagnosis of diabetes mellitus, fasting blood glucose >115 mg/dl, or hemoglobin A1c level >6.0%
Use of certain medications like corticosteroids and immunosuppressive agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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
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I am between 18 and 68 years old.
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I am approved for a complete pancreas removal and islet auto-transplant at UM.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes or my blood sugar or A1c levels are high.
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I am not taking corticosteroids or immunosuppressive drugs.
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I will need TNF alpha inhibitors for my condition.
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My IgA level is below 5 mg/dL.
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I am not planning to become pregnant and agree to use birth control.
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I have a history of HIV, hepatitis, tuberculosis, fungal lung infection, or demyelinating diseases.
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I have a blood clotting disorder or need blood-thinning medication.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximal Acute C-peptide Response to Glucose (ACRmax)
Secondary study objectives
ACRmax
AUC Glucose
Absence of Severe Hypoglycemia (SHE) With A1c <7%
+4 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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,436 Previous Clinical Trials
1,621,642 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,065 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
~5 spots leftby Dec 2025
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