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Safety and Tolerability of Pirfenidone in Acute Pancreatitis

ConditionPancreatitis, Acute
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

The goal of the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models. Following are the objectives of the proposed clinical trial:

Primary Objective:

* To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients predicted to have moderately severe or severe AP. * To evaluate the efficacy of pirfenidone in reducing the laboratory markers of inflammation and improving patient reported outcome measures.

Secondary Objective:

\- To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as measured by well-defined endpoints.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 - 85 years of age

amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values

characteristic cross-sectional imaging

typical upper abdominal pain- acute onset of a persistent, severe, epigastric pain often radiating to the back

Disqualifiers

Age < 18 or > 85 years

Body weight > 200 kg

Presentation to the medical attention > 48 h after diagnosis of AP

Inability to recruit, randomize and start the allocated treatment within 48h of start of pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pirfenidone Oral Tablet

    Drug

    Patients in the pirfenidone treatment arm will be given pirfenidone 267mg tablet, tid for 1 day followed by dose escalation to two 267 mg tablet tid for 6 days. Thus, the treatment will be for total of 7 days or till patients develop an adverse event that requires their participation in the study to be stopped.

  • Placebo

    Drug

    The placebo tablets will be an exact replica of the pirfenidone tablet.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlaceboExperimental treatment 1 intervention
Group B: Pirfenidone TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Development of anticipated or un-anticipated serious adverse events (class 3 or 4)

Development of anticipated or un-anticipated serious adverse events (class 3 or 4)

Time frame
6 months
2

percentage of patients starting and completion of the planned drug treatment

percentage of patients starting and completion of the planned drug treatment

Time frame
7 days
3

Changes in C-reactive protein (CRP), TNF-α, interleukin (IL)-6, IL-8 and IL-10 levels

Compared to base line

Time frame
7 days
4

percentage of patients having decrease in PAN-PROMISE score by at least 10 points at 72h after initiation of the drug

Measurement of PAN-PROMISE score

Time frame
3 days

Secondary outcomes

1

cumulative PAN-PROMISE score

total of the PAN-PROMISE over 7 days

Time frame
7
2

cumulative PASS score

total of PASS score during admission

Time frame
duration of admission
3

PASS score at the time of discharge

PASS score measurement

Time frame
duration of admission
4

Composition outcome

total of development of new or worsening pancreatic or peri-pancreatic necrosis, death or major infection

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Mayo Clinic

Collaborator

Source ClinicalTrials.gov
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