A Phase 4 interventional study of Thymosin Alpha 1 and normal saline in Pancreatitis, Acute Necrotizing, sponsored by Weiqin Li. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by Weiqin Li · Phase 4, Interventional, and Prevention
Among 17 studies in Pancreatitis, Acute Necrotizing with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Pancreatitis, Acute Necrotizing · China.
Among the 17 studies in Pancreatitis, Acute Necrotizing with a site in China, this one is the 2nd largest by enrollment of the 14 interventional ones, is one of 2 that started in 2018, is one of 4 in phase 4, and was the 6th registered.
74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's enrollment of 508 is above the median of 70 across 47 interventional studies indexed under Pancreatitis, Acute Necrotizing.
Browse Pancreatitis, Acute Necrotizing studies →6 of the 17 studies in Pancreatitis, Acute Necrotizing with a site in China are open now, in 2 countries. Each count lists the studies.
Of the 12 Pancreatitis, Acute Necrotizing studies recruiting now, 9 (75%) set no upper age limit and 3 (25%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2018.
Median enrollment 135 across the 14 interventional studies, 200 across the 3 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
None of the 17 has an industry lead sponsor. The 10 most frequent:
Weiqin Li is the lead sponsor of 2 studies on the registry; none are open to participants now.
Weiqin Li has 1 study filed under Pancreatitis, Acute Necrotizing — fewer than ten, so there is no comparison to draw.
4 of the studies in Pancreatitis, Acute Necrotizing with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093996Almazov National Medical Research CentreEndoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis | 2026-12-01 |
| NCT07201246West China HospitalOrgan Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy | 2026-12-30 |
| NCT06380842Chunling JiangOrgan Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy | 2026-12-30 |
| NCT07080697Zhejiang UniversityA Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension | 2027-02-28 |
Among the 17 studies in Pancreatitis, Acute Necrotizing with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.
Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied. To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP,we aimed to design this study.
Study Background \& Rationale:
Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis1, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.
Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection2, 3. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied4.
Aim of This Study:
To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP.
Sample Size Estimation:
The prevalence of pancreatic infection was reported to be around 25% in AP episodes. To demonstrate a 40% reduction in the prevalence of pancreatic infection with 80% power at a two-sided alpha level of .05, we projected an estimated sample size of 500 participants. Considering possible 2% withdraw, we plan to randomize 510 patients in total.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thymosin alpha 1 has been shown to have immunomodulatory properties
Drug: Thymosin Alpha 1
normal saline;
Drug: normal saline
In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.
Also known as: Thymosin Group
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Also known as: Placebo Group
Occurrence of pancreatic infection:
Time frame: during the index admission
The occurrence of new-onset organ failure and new-onset persistent organ failure
(SOFA score for respiration, cardiovascular, or renal system ≥2 ). New-onset is defined as events that occur after randomization and not present 24 hours before randomization
Time frame: during the index admission
In-hospital mortality
Time frame: during the index admission
Bleeding requiring intervention
Time frame: during the index admission
Gastrointestinal perforation or fistula requiring intervention
Time frame: during the index admission
Incidence of pancreatic fistula
Time frame: during the index admission
New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents
not applied 24 hours before randomization
Time frame: during the index admission
The requirement for catheter drainage/Number of drainage procedures required
Time frame: during the index admission
The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required
Time frame: during the index admission
The requirement for open surgery/Number of open surgery required
Time frame: during the index admission
Length of intensive care unit(ICU) stay/Length of hospital stay
Time frame: during the index admission
SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count
Time frame: on day0, day7, and day14
In-hospital cost.
Time frame: during the index admission
Incidence of infection within 90 days after enrollment
Time frame: 90 days after enrollment
Mortality within 90 days after enrollment
Time frame: 90 days after enrollment
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Dec 2020, 32 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thymalfasin
Pancreatitis, Acute Necrotizing →
Weiqin Li