Biliary AtresiaNCT05925309

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

A study testing Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem and Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor in people with Biliary Atresia and Cholangitis, run by Children's Hospital of Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who… Read more about this study

Who is it for?: Ages 14 to 90 days
Conditions the study is for: Biliary Atresia, Cholangitis, Anti-Bacterial Agents
What is being tested?: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem and Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 356 participants
Where: 1 siteChina
Study dates: 1 Jul 2023to 31 Dec 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

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 14 to 90 days
All sexes
No healthy volunteers
Child

Who may be able to join

Patients whose age of operation is 14-90 d. Sex and race are not restricted;
Patients who are born with gestational age older than 36 weeks;
Patients whose body weight before operation > 2 kg;
Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University;
The type-III BA diagnosis is based on cholangiography or operation;
Patients whose histological features of liver biopsies are reported. HE staining and Masson staining are required, and edema, inflammation, fibrosis, and hyperplasia of intrahepatic bile duct should be reported;
Patients who are not allergic to postoperative medications;
Patients who haven't accepted other antibiotic or probiotic therapy.

Who cannot join

Patients with cholestasis of non-BA disease;
Patients who have undergone KP at other institutions;
Patients whose pathohistological diagnosis is in doubt;
Patients who undergo liver transplantation immediately after KP;
Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy;
Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral dysplasia, etc.) and have poor prognosis;
Patients judged by the researchers that they can not comply with the study requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gong Chen, Phd contact

(+86)13918330650

chengongzlp@hotmail.com

Di Chen contact

(+86)18930942535

george19981206@126.com

China1 site, 1 recruiting

Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Di Chen, (+86)18930942535, george19981206@126.com
Recruiting

Other trials in China

About this study

Official title: Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

Read the detailed description

Biliary atresia (BA) is a devastating inflammatory obstructive neonatal disease affecting intrahepatic and extrahepatic bile ducts. Kasai portoenterostomy (KP) is the mainstay of treatment for BA. Cholangitis is a common complication after KP, with an overall incidence of 22-93%, and an incidence of 30-70% within 6 months after KP. The mechanism of cholangitis may be intestinal bacteria ascending into the intrahepatic biliary system or bacterial colonization, etc. Common causative organisms include Klebsiella, Escherichia coli, Pseudomonas aeruginosa, Enterobacter cloacae, Acinetobacter baumannii, Streptococcus, and Salmonella typhi. There is some controversy about prophylactic antibiotics after KP, and the type, dosage and course of antibiotics in medical institutions around the world vary greatly. After years of improvement, although the postoperative management and short-term prognosis of BA have improved, the overall incidence of cholangitis has not changed much. High-quality evidence for antibiotic prophylaxis after KP remains lacking. It still remains unknown that whether long-term prophylactic oral antibiotics could benefit the patients. Long-term use of antibiotics may not only increase the burden of liver dysfunction in patients, but also lead to antibiotic resistance, intestinal flora disturbance, and increase the risk of allergies and autoimmune diseases. It is of great significance to use evidence-based medicine to find a relatively reasonable cholangitis prevention program.

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics after KP and those who did not. Patients diagnosed with type III BA and receiving KP at Children's Hospital of Fudan University will be assigned to 2 groups. Both groups received the same basic treatment, then the patients in the antibiotics group received prophylactic oral antibiotics until the 6th month after KP, while the non-antibiotics group no longer used prophylactic antibiotics until cholangitis occurred. The cholangitis rate within 6 months after KP were measured to evaluate the preventive effect of prophylactic oral antibiotics on cholangitis. The patients were followed up for 2 years after KP.

Conditions: Biliary Atresia, Cholangitis, Anti-Bacterial Agents
Being tested: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem, Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
Medical subject headings: Biliary Atresia, Cholangitis

What participants receive

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

Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenemDrug
Sulperazone 50mg/kg q8h is used intravenously from the first day to the 14th day after KP surgery. Ursodeoxycholic acid 20mg/kg/d p.o, starting from the 5th day after surgery for at least 2 years. Compound glycyrrhizin 20mg/d i.v, 1-4 days after operation, then switch to compound glycyrrhizin tablets 12.5mg b.i.d p.o until 6 months after KP. Methylprednisolone start at 4mg/kg/d i.v on the 8th day after operation, and decrease by 1mg/kg/d every three days. Starting at about the 15th day after operation, methylprednisolone 4mg/kg is given orally every other day, and the dose is gradually reduced at 10-12 weeks. Vitamin AD , D , E , K, are given orally from the 5th day after the KP for at least 2 months. Treatment of cholangitis: sulperazone 50mg/kg q8h i.v., and methylprednisolone could be used. If cholangitis is not controlled, imipenem or meropenem may be used.
Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclorDrug
Compound sulfamethoxazole tablet (SMZ/TMP) 25 mg/kg/d p.o. and cefaclor 12.5 mg/kg/d p.o. alternately every 2 weeks, from post-operation day 15 to month 6.

Study groups in NCT05925309
Study group	Role	What they receive
Antibiotics group	Active comparator	Basic treatment + Prophylactic oral antibiotics Receives: Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem; Drug: Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
Non-antibiotics group	Experimental	Basic treatment Receives: Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem

What is being measured

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

The occurrence of cholangitis (confirmed or suspected) within 6 months after KP
Definition of cholangitis:
1. Clinical elements
2. Fever and/or shivering;
3. Stool color change;
4. New/increasing jaundice;
5. Abdominal discomfort: vomiting, poor, feeding, irritability.
6. Laboratory and imaging elements
7. Inflammatory response (WBC and/or CRP and/or PCT);
8. Increased/increasing transaminases;
9. Increased/increasing GGT and/or bilirubin;
10. Bile lakes.
Suspected cholangitis: one item in A + one item in B. Confirmed cholangitis: two items in A + two items in B or "suspected cholangitis" + positive blood culture.
The diagnosis of cholangitis requires the exclusion of definite infections of other systems.
Measured: 6 months after KP

Secondary outcomes (12)

The occurrence of cholangitis (confirmed or suspected) within 1 year after KP
The definition of cholangitis is the same as primary outcome.
Measured: 1 year after KP
The occurrence of jaundice clearance within 6 months after KP
Jaundice clearance is defined as total bilirubin (TB) less than 20 μmol/L.
Measured: 6 months after KP
The occurrence of jaundice clearance within 1 year after KP
Jaundice clearance is defined as TB less than 20 μmol/L.
Measured: 1 year after KP
The number of cholangitis recurrence within 6 months after KP
The definition of cholangitis is the same as primary outcome.
Measured: 6 months after KP
The number of cholangitis recurrence within 1 year after KP
The definition of cholangitis is the same as primary outcome.
Measured: 1 year after KP
The patient survive with native liver or not within 2 years after KP
Measured: 2 years after KP
The weight gain of the patients from pre-operation to 6 months post KP
Weight for height (length) Z-score is calculated based on the gender, age, and weight reference standards for children in China. The difference in weight for height (length) Z-score between pre-operation and 6 months post KP is regarded as weight gain.
Measured: From pre-operation to 6 months post KP
The weight gain of the patients from pre-operation to 1 year post KP
Weight for height (length) Z-score is calculated based on the gender, age, and weight reference standards for children in China. The difference in weight for height (length) Z-score between pre-operation and 1 year post KP is regarded as weight gain.
Measured: From pre-operation to 1 year post KP
Liver parameters at post-operation month 6
Liver parameters: pediatric end-stage liver disease (PELD) score, liver stiffness measurement.
PELD score = [0.480×ln (total bilirubin) + 1.857×ln (international normalized ratio)-0.687×ln (albumin) + 0.436 × age score + 0.667 × growth arrest] × 10. Age score:1 point for age < 24 months, 0 for age ≥ 24 months. Growth arrest: 1 point for more than 2 standard deviations below the average, otherwise 0.
Liver stiffness measurement is measured by liver transient elastography.
Measured: 6 months after KP
Liver parameters at post-operation month 12
Liver parameters: pediatric end-stage liver disease (PELD) score, liver stiffness measurement.
PELD score = [0.480×ln (total bilirubin) + 1.857×ln (international normalized ratio)-0.687×ln (albumin) + 0.436 × age score + 0.667 × growth arrest] × 10. Age score:1 point for age < 24 months, 0 for age ≥ 24 months. Growth arrest: 1 point for more than 2 standard deviations below the average, otherwise 0.
Liver stiffness measurement is measured by liver transient elastography.
Measured: 1 year after KP
Changes in intestinal flora from post-operation week 2 to month 3
Fecal samples of 40 patients in each group are collected 2 weeks and 3 months after KP, and frozen at -80℃. 16s-rDNA sequencing is used to find out the changes in intestinal flora.
Measured: From post-operation week 2 to month 3
Changes in intestinal flora from post-operation week 2 to month 6
Fecal samples of 40 patients in each group are collected 2 weeks and 6 months after KP, and frozen at -80℃. 16s-rDNA sequencing is used to find out the changes in intestinal flora.
Measured: From post-operation week 2 to month 6

Timeline

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

1 Jul 202331 Dec 2029

First posted29 Jun 2023
Study start1 Jul 2023
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Biliary AtresiaStudies of the same condition, open and under way.
More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 356 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05925309
Sponsor's protocol ID: PACK
Status last verified: May 2026
First submitted: 14 Jun 2023
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Calinescu AM, Madadi-Sanjani O, Mack C, Schreiber RA, Superina R, Kelly D, Petersen C, Wildhaber BE. Cholangitis Definition and Treatment after Kasai Hepatoportoenterostomy for Biliary Atresia: A Delphi Process and International Expert Panel. J Clin Med. 2022 Jan 19;11(3):494. doi: 10.3390/jcm11030494.
PubMed 35159946
Chen G, Liu J, Huang Y, Wu Y, Lu X, Dong R, Shen Z, Sun S, Jiang J, Zheng S. Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial. Pediatr Surg Int. 2021 Aug;37(8):1089-1097. doi: 10.1007/s00383-021-04916-z. Epub 2021 May 19.
PubMed 34013444
Decharun K, Leys CM, West KW, Finnell SM. Prophylactic Antibiotics for Prevention of Cholangitis in Patients With Biliary Atresia Status Post-Kasai Portoenterostomy: A Systematic Review. Clin Pediatr (Phila). 2016 Jan;55(1):66-72. doi: 10.1177/0009922815594760. Epub 2015 Jul 15.
PubMed 26183324
Vangay P, Ward T, Gerber JS, Knights D. Antibiotics, pediatric dysbiosis, and disease. Cell Host Microbe. 2015 May 13;17(5):553-64. doi: 10.1016/j.chom.2015.04.006.
PubMed 25974298

Interested in taking part?

Gong Chen, Phd

(+86)13918330650

chengongzlp@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Biliary Atresia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05925309
Acronym / sponsor ID: PACK
Conditions: Biliary Atresia, Cholangitis, Anti-Bacterial Agents
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 356 participants (estimated)
Lead sponsor: Children's Hospital of Fudan UniversityUniversity, hospital or other
Study start: 1 Jul 2023 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 29 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Antibiotics group	Active comparator	Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem, Drug: Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclorBasic treatment + Prophylactic oral antibiotics
Non-antibiotics group	Experimental	Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenemBasic treatment

Who may qualify

Ages: 14 to 90 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Patients whose age of operation is 14-90 d. Sex and race are not restricted;
Patients who are born with gestational age older than 36 weeks;
Patients whose body weight before operation > 2 kg;
Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University;
The type-III BA diagnosis is based on cholangiography or operation;

Key exclusion criteria (7 listed)

Patients with cholestasis of non-BA disease;
Patients who have undergone KP at other institutions;
Patients whose pathohistological diagnosis is in doubt;
Patients who undergo liver transplantation immediately after KP;
Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenemSulperazone 50mg/kg q8h is used intravenously from the first day to the 14th day after KP surgery. Ursodeoxycholic acid 20mg/kg/d p.o, starting from the 5th day after surgery for at least 2 years. Compound glycyrrhizin 20mg/d i.v, 1-4 days after operation, then switch to compound glycyrrhizin tablets 12.5mg b.i.d p.o until 6 months after KP. Methylprednisolone start at 4mg/kg/d i.v on the 8th day after operation, and decrease by 1mg/kg/d every three days. Starting at about the 15th day after operation, methylprednisolone 4mg/kg is given orally every other day, and the dose is gradually reduced at 10-12 weeks. Vitamin AD , D , E , K, are given orally from the 5th day after the KP for at least 2 months. Treatment of cholangitis: sulperazone 50mg/kg q8h i.v., and methylprednisolone could be used. If cholangitis is not controlled, imipenem or meropenem may be used.	Drug	Antibiotics group, Non-antibiotics group
Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclorCompound sulfamethoxazole tablet (SMZ/TMP) 25 mg/kg/d p.o. and cefaclor 12.5 mg/kg/d p.o. alternately every 2 weeks, from post-operation day 15 to month 6.	Drug	Antibiotics group

Primary outcome

The occurrence of cholangitis (confirmed or suspected) within 6 months after KP
Time frame: 6 months after KP
Definition of cholangitis: A. Clinical elements 1. Fever and/or shivering; 2. Stool color change; 3. New/increasing jaundice; 4. Abdominal discomfort: vomiting, poor, feeding, irritability. B. Laboratory and imaging elements 1. Inflammatory response (WBC and/or CRP and/or PCT); 2. Increased/increasing transaminases; 3. Increased/increasing GGT and/or bilirubin; 4. Bile lakes. Suspected cholangitis: one item in A + one item in B. Confirmed cholangitis: two items in A + two items in B or "suspected cholangitis" + positive blood culture. The diagnosis of cholangitis requires the exclusion of definite infections of other systems.

12 secondary outcomes

The occurrence of cholangitis (confirmed or suspected) within 1 year after KP
Time frame: 1 year after KP
The occurrence of jaundice clearance within 6 months after KP
Time frame: 6 months after KP
The occurrence of jaundice clearance within 1 year after KP
Time frame: 1 year after KP
The number of cholangitis recurrence within 6 months after KP
Time frame: 6 months after KP
The number of cholangitis recurrence within 1 year after KP
Time frame: 1 year after KP
The patient survive with native liver or not within 2 years after KP
Time frame: 2 years after KP
The weight gain of the patients from pre-operation to 6 months post KP
Time frame: From pre-operation to 6 months post KP
The weight gain of the patients from pre-operation to 1 year post KP
Time frame: From pre-operation to 1 year post KP
Liver parameters at post-operation month 6
Time frame: 6 months after KP
Liver parameters at post-operation month 12
Time frame: 1 year after KP
Changes in intestinal flora from post-operation week 2 to month 3
Time frame: From post-operation week 2 to month 3
Changes in intestinal flora from post-operation week 2 to month 6
Time frame: From post-operation week 2 to month 6

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Background: PubMed 35159946Calinescu AM, Madadi-Sanjani O, Mack C, Schreiber RA, Superina R, Kelly D, Petersen C, Wildhaber BE. Cholangitis Definition and Treatment after Kasai Hepatoportoenterostomy for Biliary Atresia: A Delphi Process and International Expert Panel. J Clin Med. 2022 Jan 19;11(3):494. doi: 10.3390/jcm11030494.
Background: PubMed 34013444Chen G, Liu J, Huang Y, Wu Y, Lu X, Dong R, Shen Z, Sun S, Jiang J, Zheng S. Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial. Pediatr Surg Int. 2021 Aug;37(8):1089-1097. doi: 10.1007/s00383-021-04916-z. Epub 2021 May 19.
Background: PubMed 26183324Decharun K, Leys CM, West KW, Finnell SM. Prophylactic Antibiotics for Prevention of Cholangitis in Patients With Biliary Atresia Status Post-Kasai Portoenterostomy: A Systematic Review. Clin Pediatr (Phila). 2016 Jan;55(1):66-72. doi: 10.1177/0009922815594760. Epub 2015 Jul 15.
Background: PubMed 25974298Vangay P, Ward T, Gerber JS, Knights D. Antibiotics, pediatric dysbiosis, and disease. Cell Host Microbe. 2015 May 13;17(5):553-64. doi: 10.1016/j.chom.2015.04.006.
Individual participant dataSharing planned: No

Related trials for Biliary Atresia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Gong Chen, Phd contact

(+86)13918330650

chengongzlp@hotmail.com

Di Chen contact

(+86)18930942535

george19981206@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Gong Chen, Phd ((+86)13918330650, chengongzlp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of cholangitis (confirmed or suspected) within 6 months after KP (time frame: 6 months after KP). 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 NCT05925309, which also lists 4 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 15 May 2026.