Acute pancreatitis MedDRA version: 16.0 Level: LLT Classification code 10000971 Term: Acute pancreatitis System Organ Class: 100000004856
Conditions
Interventions
Product Code: DP-b99
Pharmaceutical Form: Lyophilisate for solution for infusion
CAS Number: 222315-66-4
Current Sponsor code: DP-b99
Other descriptive name: Chemical name: 1,2-Bis(2-aminophenoxy)etha
Sponsors
D-Pharm Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subject. • Age 18 years or higher. • First in a lifetime episode of acute pancreatitis. • Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: - Typical upper abdominal pain. - Elevation of serum amylase and/or lipase 3 times the upper limit of normal. - Contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis. • History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening). • BISAP score >= 3. • Study treatment initiation is possible within 48 h of symptom onset. • Ability to provide informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • Drug-induced, viral, hereditary or post-ERCP pancreatitis. • Recurrent episode of pancreatitis. • CT evidence of pancreatic necrosis at study entry. • Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter > 6 mm (above 80 years, > 8 mm) with gallbladder in situ. • Severe chronic renal failure (Modification of Diet in Renal Disease formula 45% at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset). • Serum ALT >250 IU/L at study entry. • Clinical suspicion of ascending cholangitis at study entry. • Active gastrointestinal bleeding. • Current malignancy not in remission (other than basal cell carcinoma of skin). • Altered mental status. • Current breast feeding or pregnancy. • Female of childbearing potential (< 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)) for the duration of the trial. • Known hypersensitivity to any component of the investigational product. • Dependent relationship with the investigator or the sponsor. • Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effects of DP-b99 in subjects with high risk acute pancreatitis on systemic inflammation. ;Secondary Objective: Effects of DP-b99 in subjects with high risk acute pancreatitis on • Safety • Early clinical outcome (preliminary data);Primary end point(s): The primary study endpoint is to assess the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels.;Timepoint(s) of evaluation of this end point: Days 0, 1, 2, 3, 4, 5, 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pharmacodynamics (PD) (1) Plasma concentrations of TNF-alpha, IL-6, MMP-9. • Safety (2) Physical examination, (3) Vital signs (heart rate, systolic/diastolic blood pressure, body temperature, respiratory rate), (4) 12-lead ECG, (5) Adverse events, (6) Safety laboratory test (clinical chemistry, hematology, urinalysis). • Clinical (7) Systemic inflammatory response syndrome (SIRS) score, (8) Acute Physiology and Chronic Health Evaluation II (APACHE II) score, (9) AUCD0-6 for the SIRS score, (10) death or persistent single- or multiple-organ failure, (11) characteristics of pancreas morphology in abdominal CT. • Pharmacokinetics (PK) (12) Plasma concentrations of DP d99. ;Timepoint(s) of evaluation of this end point: 1: Days 0, 1, 2, 3, 4, 5, 6 2: Days 0, 1, 2, 3, 4, 5, 6, 14 3, Vital signs – heart rate, systolic/diastolic blood pressure: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6 3, Vital signs – body temperature: Days 0, 1, 2, 3, 4, 5, 6, 14 4: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6 5: Day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6, day 14 6: Days 0, 1, 2, 3, 4, 5, 6, 14 7: Days 0, 1, 2, 3, 4, 5, 6 8: Days 0, 1, 2 9: Days 0 to 6 10: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6, day 14 11: Day 0 (at the investigator’s discretion), day 3 12:Day 1 (12 h and 24 h), day 2 (36 h and 48 h) | — |
Countries
Czech Republic, Slovakia
Contacts
Public ContactProject management
FGK Clinical Research s.r.o.
Outcome results
None listed