Hereditary Pancreatitis Clinical Trials

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Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed consent.

• Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria:

• A definitive diagnosis of CP is established by one or more of the following additional criteria:

• i) Pancreatic calcification

• ii) Moderate or marked ductal lesions (according to the Cambridge classification)

• iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation

• iv) Histological verification of CP

• A probable diagnosis of CP is established by one or more of the following additional criteria:

• i) Mild ductal alterations (according to the Cambridge classification)

• ii) Recurrent or persistent pseudocysts

• iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test)

• iv) Diabetes mellitus

• Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back).

• Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria:

• i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level.

• ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection.

• iii) Signs of pancreatic inflammation on cross-sectional imaging.

• ≥ 18 years of age

• The participant must be able to read and understand the informed consent forms.

• The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures.

Locations
Other Locations
Denmark
Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital
RECRUITING
Aalborg
Contact Information
Primary
Rasmus Hagn-Meincke, MD
r.hagnmeincke@rn.dk
004597663520
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2026-06
Participants
Target number of participants: 36
Treatments
Active_comparator: Tocilizumab
8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %)
Placebo_comparator: Placebo
100 ml sodium chloride 9 mg/mL (0.9 %).
Sponsors
Collaborators: Viborg Regional Hospital, Stanford University, Haukeland University Hospital, University of Aarhus, Aarhus University Hospital
Leads: Soren Schou Olesen

This content was sourced from clinicaltrials.gov