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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 60 follow-up
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test whether giving a single dose of RABI-767 through endoscopic ultrasound (EUS) guided peripancreatic injection is safe and effective for patients with severe acute pancreatitis
Who is the study for?
This trial is for people with severe acute pancreatitis, confirmed by specific imaging tests (CECT or CEMRI), who haven't improved significantly since being admitted to the hospital. Participants must be suitable for a procedure that uses an endoscope to deliver the study drug near the pancreas.
What is being tested?
The trial is testing RABI-767, administered once via an endoscopic ultrasound around the pancreas, against supportive care alone. The goal is to see if this single dose can safely and effectively treat severe acute pancreatitis.
What are the potential side effects?
While not explicitly listed in your summary, side effects may include reactions at the injection site, potential complications from endoscopic procedures, and any unforeseen effects of RABI-767 on pancreatic function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 60 follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 60 follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events
Number of Participants with Serious Adverse Events
Secondary study objectives
Development of Local Complications of Acute Pancreatitis
Development of New Onset Infection
Development of New Onset Moderately Severe Acute Pancreatitis
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RABI-767 plus Standard-of-CareExperimental Treatment1 Intervention
Single-dose 125 mg RABI-767 plus standard-of-care
Group II: Standard-of-Care OnlyActive Control1 Intervention
No Intervention, Standard-of-Care Only
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Who is running the clinical trial?
Panafina, Inc.Lead Sponsor
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