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Panafina RABI-767-201

  • Status
    Accepting Candidates
  • Age
    18 Years - 85 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis.

The main question the study aims to answer is:

鈥� Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis.

The study also aims to answer:

鈥� Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis.

Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only.

The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.

Details

Full study title A Phase 2a, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants with Predicted Severe Acute Pancreatitis
Protocol number OCR44913
ClinicalTrials.gov ID NCT06080789
Phase Phase 2

Eligibility

Key Inclusion Criteria:

  • Diagnosis of acute pancreatitis

  • Predicted severe acute pancreatitis, based on protocol defined criteria

  • Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization

  • Suitable for EUS-guided study drug administration procedure

  • Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria

Key Exclusion Criteria:

  • Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classification of Acute Pancreatitis (ie, Persistent [> 48 hours] organ failure, per Modified Marshall Score), prior to randomization

  • Anticipated discharge from hospital within 48 hours of randomization

  • More than 30% pancreatic necrosis on screening CECT or MRI

  • History of previous pancreatic necrosis, including necrosectomy

  • History of calcific chronic pancreatitis

  • Evidence of cholangitis

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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