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Cohort 1 for Acute Pancreatitis (SNAP Trial)

Phase 2
Waitlist Available
Led By Timothy B Gardner, MD
Research Sponsored by ChiRhoClin, 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, day 2, day 3, 96 hours and through study completion an average of day 7
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

Acute pancreatitis is a frequently devastating pancreatic inflammatory process that results in extensive morbidity, mortality, and hospitalization costs. The incidence of acute pancreatitis has been increasing over the last decade with an overall mortality rate of 5%, although it may be as high as 30% in the most severe cases. It was the most common inpatient gastrointestinal diagnosis in 2009, totaling over 270,000 hospitalizations with estimated "inpatient costs" of over 2.5 billion dollars in the United States. However, despite the significant impact to both patients and the healthcare system, there is no proven pharmacologic therapy that improves important clinical outcomes in acute pancreatitis. The release of bicarbonate rich fluid into the pancreatic duct from the ductal cells is an important mechanism to protect against pancreatitis by two distinct mechanisms: 1. "Flushing" activated enzymes out of the pancreas and into the duodenum thereby preventing accumulation of activated enzymes within the pancreatic acinus 2. Directly alkalinizing the acinar cells, which limits intra-acinar cell damage by improving trafficking of inappropriately activated intra-acinar enzymes along the apical membrane. In addition to standard care, patients will be divided into 4 cohorts. Cohorts 1,2 and 3 will be treated with different doses of intravenous synthetic human secretin. Cohort X will not receive human secretin, but all datapoints and specimens will be collected. The patient cohorts will be entered into the study as follows: Cohort X; Cohort 1; Cohort 2; Cohort 3. 5 patients in each cohort will be evaluated at each center (for a total of n=10 at both centers for each cohort). Dosing will start within 24 hours of hospitalization with no further synthetic human secretin administration beyond Day 3. Patients will continue to be followed for 7 days or until discharge, whichever comes first. Any data recorded to that point would be included in an intent-to-treat analysis. The primary objective is to perform a Phase II Pilot Study to explore the efficacy of intravenous synthetic human secretin as a pharmacologic adjunct to modulate the severity of human acute (non-obstructive) pancreatitis.

Eligible Conditions
  • Acute Pancreatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, day 3, 96 hours and through study completion an average of day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 3, 96 hours and through study completion an average of day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CRP level
Secondary study objectives
Pro- and anti-inflammatory markers
Other study objectives
Pancreatitis
Change in Hemoconcentration measurement
Change in Hemoconcentration measurements
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Active Control
Group I: Cohort XActive Control1 Intervention
no secretin administered. All observations
Group II: Cohort 1Active Control1 Intervention
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin two times a day (40 mcg; q 12 hrs)
Group III: Cohort 2Active Control1 Intervention
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin four times a day (40 mcg; q 6 hrs)
Group IV: Cohort 3Active Control1 Intervention
32 mcg (\<50kg) or 40 mcg (≥50kg) secretin six times a day (40 mcg; q 4 hrs)

Find a Location

Who is running the clinical trial?

ChiRhoClin, Inc.Lead Sponsor
9 Previous Clinical Trials
9,865 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterOTHER
537 Previous Clinical Trials
2,540,013 Total Patients Enrolled
1 Trials studying Acute Pancreatitis
40 Patients Enrolled for Acute Pancreatitis
Timothy B Gardner, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
~6 spots leftby Nov 2025