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NCT02713997 · ClinicalTrials.gov registry record · Phase 4
Anti-inflammatory Therapy to Improve Outcomes After TPIAT
A Phase 4 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT02713997 is a Phase 4 study that has completed, run by University of Minnesota. The registered enrollment target is 43 participants.
The verdict
NCT02713997, a Phase 4 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
Patients with severe chronic pancreatitis may be candidates to have their pancreas removed and their islets transplanted into the liver to reduce the risk of diabetes mellitus, a procedure called total pancreatectomy with islet autotransplant (TPIAT). However, over half of patients who have a TPIAT will need to remain on some supplemental insulin life-long after the procedure. We will study therapies that may reduce damage to transplanted islets, and thereby improve long-term outcomes. Two promising anti-inflammatory therapies are available to protect islets from damage at the time of transplant: (1) the Tumor Necrosis Factor (TNF)-alpha inhibitor etanercept and (2) the serine protease inhibitor alpha-1 antitrypsin. Both agents are commercially available for clinical trials. Proof-of-principle for etanercept has been demonstrated in type 1 diabetic allotransplant recipients, in whom a 10 day course of etanercept early post-transplant significantly improved long-term insulin independence, due to better survival of the transplanted beta cell mass in the engraftment period. Alpha-1 antitrypsin (A1AT) reduces inflammatory cytokines, protects against cytokine-induced beta cell apoptosis, and prolongs islet graft survival in mice and intraportal IAT non-human primates. This initial 3-arm drug-treatment clinical trial will investigate the use of Etanercept and A1AT to improve IAT function at 90 days and 1 and 2 years post-TPIAT compared to standard care. Forty-five patients undergoing TPIAT will be randomized 1:1:1 to receive either: 1) etanercept (50 mg on day 0; 25 mg on days 3, 7, 10, 14, and 21), 2) alpha-1 antitrypsin (90 mg/kg IV days -1, +3, 7, 14, 21, 28) or 3) standard care. Patients will have mechanistic assessments drawn in the early post-operative period including inflammatory cytokines and chemokines and measures of beta cell loss. Metabolic testing will occur at 90, 365, and 730 days post-TPIAT, including mixed meal tolerance testing, IV glucose tolerance t
Interventions
- DRUG Alpha 1-Antitrypsin
- DRUG etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-12 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02713997
The ClinicalTrials.gov registry entry for NCT02713997 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alpha 1-Antitrypsin is the first listed.
NCT02713997 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02713997 about?
NCT02713997 is a clinical study titled "Anti-inflammatory Therapy to Improve Outcomes After TPIAT". Patients with severe chronic pancreatitis may be candidates to have their pancreas removed and their islets transplanted into the liver to reduce the risk of diabetes mellitus, a procedure called total pancreatectomy with islet autotransplant (TPIAT). However, over half of patients who have a TPIAT ...
What is the current status of trial NCT02713997?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2016-12. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT02713997?
The interventions under investigation include: Alpha 1-Antitrypsin (DRUG), etanercept (DRUG).
Who is sponsoring clinical trial NCT02713997?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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