AzTrials
AzTrials

Pancreatitis, Acute NecrotizingPhase 4TRACENCT02473406

Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis

A Phase 4 study testing Thymosin Alpha 1 and normal saline in people with Pancreatitis, Acute Necrotizing, run by Weiqin Li at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatitis, Acute Necrotizing
What is being tested?
Thymosin Alpha 1 and normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
508 participants
Where
2 sitesChina
Study dates
27 Mar 2018to 24 Mar 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography or less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography according to the Revised Atlanta Criteria[15];
  • Less than one week from the onset of abdominal pain;
  • Age between 18 to 70 years old;
  • Acute Physiology and Chronic Health Evaluation(APACHE II) score ≥8 during the last 24 hours before enrollment
  • Balthazar CT score ≥5 (presence of pancreatic necrosis)[16].
  • Written informed consent obtained

Who cannot join

  • Pregnant pancreatitis;
  • History of chronic pancreatitis；
  • Malignancy related acute pancreatitis
  • Receiving early intervention or surgery due to abdominal compartment syndrome or other reasons before admission；
  • Patients with a known history of severe cardiovascular, respiratory, renal or hepatic diseases defined as (1) greater than New York Heart Association Class II heart failure(Class II not included), (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen;
  • Patients with preexisting immune disorders such as AIDS.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China

    Nanjing, Jiangsu, 210002

  • Jinling Hospital

    Nanjing, Jiangsu, 210010

Other trials in China

About this study

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.

Read the detailed description

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.

Being tested
Thymosin Alpha 1, normal saline
Keywords
Acute Pancreatitis, prevent,Necrotizing
Medical subject headings
Pancreatitis, Acute Necrotizing, Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thymosin Alpha 1Drug

    Also called Thymosin Group

    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.

  • normal salineDrug

    Also called Placebo Group

    Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.

Study groups in NCT02473406
Study groupRoleWhat they receive
ThymosinExperimentalThymosin alpha 1 has been shown to have immunomodulatory properties
Receives: Drug: Thymosin Alpha 1
PlaceboPlacebo comparatornormal saline;
Receives: Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of pancreatic infection:

    Measured: during the index admission

Secondary outcomes (14)

  1. 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

    Measured: during the index admission

  2. In-hospital mortality

    Measured: during the index admission

  3. Bleeding requiring intervention

    Measured: during the index admission

  4. Gastrointestinal perforation or fistula requiring intervention

    Measured: during the index admission

  5. Incidence of pancreatic fistula

    Measured: during the index admission

  6. New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents

    not applied 24 hours before randomization

    Measured: during the index admission

  7. The requirement for catheter drainage/Number of drainage procedures required

    Measured: during the index admission

  8. The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required

    Measured: during the index admission

  9. The requirement for open surgery/Number of open surgery required

    Measured: during the index admission

  10. Length of intensive care unit(ICU) stay/Length of hospital stay

    Measured: during the index admission

  11. SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count

    Measured: on day0, day7, and day14

  12. In-hospital cost.

    Measured: during the index admission

  13. Incidence of infection within 90 days after enrollment

    Measured: 90 days after enrollment

  14. Mortality within 90 days after enrollment

    Measured: 90 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study start27 Mar 2018
  3. Primary completion24 Dec 2020
  4. Study completion24 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473406
Sponsor's protocol ID
TRACE trial
Acronym
TRACE
Status last verified
Apr 2021
First submitted
12 Jun 2015
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial. Gut Liver. 2024 Sep 15;18(5):906-914. doi: 10.5009/gnl230326. Epub 2024 Feb 15.

    PubMed 38356344

  • Ke L, Mao W, Shao F, Zhou J, Xu M, Chen T, Liu Y, Tong Z, Windsor J, Ma P, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Association between pretreatment lymphocyte count and efficacy of immune-enhancing therapy in acute necrotising pancreatitis: a post-hoc analysis of the multicentre, randomised, placebo-controlled TRACE trial. EClinicalMedicine. 2023 Mar 24;58:101915. doi: 10.1016/j.eclinm.2023.101915. eCollection 2023 Apr.

    PubMed 37007743

  • Zhou J, Mao W, Ke L, Chen T, He W, Pan X, Chen M, He C, Gu W, Wu J, Song J, Ni H, Tu J, Sun J, Zhang G, Chen W, Xue B, Zhao X, Shao M, Liu Y, Tong Z, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial. BMJ Open. 2020 Sep 29;10(9):e037231. doi: 10.1136/bmjopen-2020-037231.

    PubMed 32994239

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Thymosin Alpha 1 and normal saline in people with Pancreatitis, Acute Necrotizing, run by Weiqin Li at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of pancreatic infection: (time frame: during the index admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473406, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in