Testing different doses of an anti-inflammatory medicine called ulinastatin given early to people with severe pancreas inflammation

ISRCTN	ISRCTN33507694
DOI	https://doi.org/10.1186/ISRCTN33507694
Sponsor	Nanjing University
Funder	Techpool Bio-pharma Co., Ltd

Submission date: 12/10/2026
Registration date: 13/10/2026
Last edited: 13/10/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lu Ke
Principal investigator

No.305 East Zhongshan Road
Nanjing
210000
China

Phone	+86 02580861893
Email	kelu@nju.edu.cn

Dr Longxiang Cao
Public, Scientific

No.305 East Zhongshan Road
Nanjing
210000
China

Phone	+86 13270806915
Email	caolongxiang321@126.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Dose comparison
Assignment	Parallel
Purpose	Treatment
Scientific title	Efficacy and optimal dosage of early intravenous ulinastatin therapy in patients with early hyperinflammatory acute pancreatitis: a multicenter, double-blind, bayesian multi-arm multi-stage randomized controlled trial
Study objectives
Ethics approval(s)	Approved 24/03/2026, Ethics Committee of Jinling Hospital (Official Military Name: Clinical Research Ethics Committee of the General Hospital of Eastern Theater Command, PLA, No.305 East Zhongshan Road, Nanjing, 210000, China; +86 025-80863234; 622024350067@smail.nju.edu.cn), ref: 2026DZKY-035-02
Health condition(s) or problem(s) studied	Efficacy and optimal dose of ulinastatin in patients with acute pancreatitis
Intervention	Participants will be randomized centrally 1:1:1:1 using an interactive web response system (IWRS) to intravenous ulinastatin 800,000 U, 400,000 U, 100,000 U, or placebo. Each dose was diluted in 100 mL 0.9% sodium chloride and infused IV over 1–2 h every 8 h for 7 days (21 doses). If discharged early, treatment continued until the day before discharge. To maintain blinding of participants, investigators, and outcome assessors, the infusion bag were concealed with an opaque cover, and allocation information was not disclosed.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	ulinastatin
Primary outcome measure(s)	Incidence of severe acute pancreatitis (SAP) within 14 days, defined as the occurrence of persistent (>48 h) organ failure; organ failure was defined as a single-system Sequential Organ Failure Assessment (SOFA-2) score ≥2, measured using electronic health records at the end of the study at day 14
Key secondary outcome measure(s)	Organ failure-free days within 14 days, defined as a single-system SOFA-2 score ≥2, measured using the SOFA-2 score at daily time points from randomization to 14 days Incidence of new-onset organ failure, defined as a single-system SOFA-2 score ≥2, measured using the SOFA-2 score. Baseline organ function is documented at randomization. New-onset organ failure is that is absent at baseline and persists for >48 h; at daily time points from randomization to 14 days Incidence of new receipt of organ support therapy, defined as initiation of one or more of the following in a participant who was not receiving that therapy at baseline: invasive mechanical ventilation, vasopressors, or renal replacement therapy, measured using electronic health records at 14 days Incidence of infected pancreatic necrosis, defined according to the revised Atlanta classification as pancreatic and/or peripancreatic necrosis with documented infection, measured using electronic health records at 28 days Systemic Inflammatory Response Syndrome (SIRS) free days, defined according to standard criteria as the presence of ≥2 of the following: Temperature >38°C or <36°C; Heart rate >90 beats/min; Respiratory rate >20 breaths/min or PaCO₂ <32 mmHg; White blood cell count >12,000/mm³ or <4,000/mm³, or >10% band forms, measured using electronic health records at 14 days Duration of ICU stay measured using ICU admission and discharge dates/times are prospectively recorded from the medical record. Duration of ICU stay is calculated as the time from ICU admission to the first ICU discharge; at 28 days Overall mortality within 28 days measured using medical records, death certificates, and/or structured follow-up contacts at day 28
Completion date	31/10/2030

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	640
Key inclusion criteria	1. Age from 18 and 75 years 2. Diagnosed AP 3. Presence of Systemic Inflammatory Response Syndrome (SIRS) and/or CRP>150 mg/L 4. Anticipated initiation of the first dose within 48 hours of AP diagnosis
Key exclusion criteria	1. Concurrent acute cholangitis requiring urgent Endoscopic Retrograde Cholangiopancreatography (ERCP) 2. Presence of a definite infection 3. Pancreatic tumor, pancreatic trauma, chronic pancreatitis, or history of pancreatic resection 4. Comorbid severe underlying diseases, such as heart failure, chronic liver disease, chronic kidney disease, severe diabetes, etc) 5. Pregnant or lactating, female subjects with a positive pregnancy test or subjects (or their partners) planning pregnancy within 6 months after the study ends 6. Known current participation or participation in another randomized controlled trial within the past 1 month 7. History of allergy to protease inhibitor 8. Other conditions considered by the investigator as unsuitable for inclusion
Date of first enrolment	01/11/2026
Date of final enrolment	31/10/2029

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

12/10/2026: Study’s existence confirmed by the Ethics Committee of Jinling Hospital, China.