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Virus Therapy

RABI-767 plus Standard-of-Care for Acute Pancreatitis

Phase 2

Recruiting

Research Sponsored by Panafina, Inc.

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 60 follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Clinical Chemistry Parameters

Change from Baseline in Hematology Parameters

Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements

+3 more

Secondary outcome measures

Change in Abdominal Pain Numeric Rating Score

Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis

Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis

+13 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Panafina, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities for individuals to enroll in this research study?

"Information from clinicaltrials.gov confirms that this medical study is currently seeking participants. The trial was initially listed on February 26, 2024, and its most recent update was made on February 28, 2024."

Answered by AI

What is the overall count of participants enrolled in this research endeavor?

"Indeed, the details on clinicaltrials.gov show that this investigation is presently seeking participants. Originally posted on February 26th, 2024, it was last modified on February 28th, 2024. The trial aims to recruit a total of 36 individuals from three distinct sites."

Answered by AI

Does the clinical trial include individuals who are 70 years old and above?

"Qualified individuals must be at least 18 years old but no older than 85 to participate in this research study."

Answered by AI

Has the combination of RABI-767 and Standard-of-Care been officially sanctioned by the FDA?

"The safety evaluation of RABI-767 in combination with Standard-of-Care received a rating of 2 on the scale from 1 to 3. This assessment is based on the absence of efficacy data and some existing safety information, indicating moderate levels of risk."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

2024. "A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06080789.

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