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Anti-Inflammatory Therapy for Chronic Pancreatitis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 4 trial • 210 Patients • NCT01313208Trial Design
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Who is running the clinical trial?
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- I have diabetes or my blood sugar or A1c levels are high.I am between 18 and 68 years old.I haven't used specific treatments in the last 30 days.I am approved for a complete pancreas removal and islet auto-transplant at UM.I am not taking corticosteroids or immunosuppressive drugs.I will need TNF alpha inhibitors for my condition.I am approved for a total pancreatectomy and IAT at the University of Minnesota.My IgA level is below 5 mg/dL.I am not planning to become pregnant and agree to use birth control.I have a history of HIV, hepatitis, tuberculosis, fungal lung infection, or demyelinating diseases.I have a blood clotting disorder or need blood-thinning medication.I am between 18 and 68 years old.
- Group 1: Standard Care
- Group 2: etanercept
- Group 3: alpha-1 antitrypsin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
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