Cholestasis of Parenteral NutritionPhase 3NCT03387579
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
A Phase 3 study testing Smoflipid 20% Lipid Emulsion for Injection and Intralipid, 20% Intravenous Emulsion in people with Cholestasis of Parenteral Nutrition, run by Indiana University at 1 site in United States.
Trial summary
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholestasis of Parenteral Nutrition
- What is being tested?
- Smoflipid 20% Lipid Emulsion for Injection and Intralipid, 20% Intravenous Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 19 Mar 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Current weight less than 750 grams
- AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
- Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
- Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5 days of age, > 1.5 older than five days of age)
- Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
- Renal failure requiring dialysis
- Cyanotic heart disease requiring prostaglandin therapy
- Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
Official title: Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
Read the detailed description
Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.
- Conditions
- Cholestasis of Parenteral Nutrition
- Being tested
- Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoflipid 20% Lipid Emulsion for InjectionDrug
Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day
Intralipid, 20% Intravenous EmulsionDrug
Also called Intralipid 20% Reduction
Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
Intralipid, 20% Intravenous EmulsionDrug
Also called Intralipid 20% Historic
Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Smoflipid 20% | Experimental | Patients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations. Receives: Drug: Smoflipid 20% Lipid Emulsion for Injection |
| Intralipid 20% Reduction | Experimental | Patients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study. Receives: Drug: Intralipid, 20% Intravenous Emulsion |
| Intralipid 20% Historic | Other | Patients who retrospectively received soy-based lipid (Intralipid) at standard dosing of 2-3 g/kg/day were eligible for inclusion. Patients in this group were matched to prospective patients based on diagnosis, gestational age, and length of lipid therapy. Receives: Drug: Intralipid, 20% Intravenous Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cholestasis
Cholestasis was defined as a direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart.
Measured: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Secondary outcomes (19)
Weight Velocity
Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.
Measured: Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity.
Length Velocity
Length velocity was defined as the difference in length from end of study compared to enrollment divided by the number of days enrolled in study.
Measured: Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity.
Head Circumference (OFC) Velocity
OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study.
Measured: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
Average Total Calorie Intake
Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis.
Measured: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
Number of Patients With Enteral Autonomy at End of Study
Percentage of patients with enteral autonomy at time of leaving or stopping study was calculated. Enteral autonomy was defined as relying on enteral nutrition only for nutrition intake with no need for parenteral nutrition supplementation.
Measured: Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks.
Number of Patients With Essential Fatty Acid Deficiency (EFAD)
Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.
Measured: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
AST Change Over Time
The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment.
Measured: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
ALT Change Over Time
The rate of change of ALT over time was compared between groups using mixed model analysis. Change of ALT was calculated as ALT at end of study compared to ALT at enrollment.
Measured: ALT measured at enrollment and every 2 weeks for max 12 weeks.
Alkaline Phosphatase Change Over Time
Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment.
Measured: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
Triglyceride Level Over Time
All enrolled patients had serum triglyceride levels monitored at enrollment and weekly. The triglyceride level changes was calculated using values at the end of study compared to enrollment with mean and standard deviation calculated for each treatment group.
Measured: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
Gamma Glutamyl Transferase (GGT) Over Time
GGT was documented at baseline and regularly intervals with level compared over time between groups. GGT was compared by treatment group for levels at end of study and enrollment.
Measured: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
Number of Patients With Retinopathy of Prematurity
The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included.
Measured: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease
The rate of BPD was documented and compared between groups. BPD was diagnosed based on need for respiratory support at 28 days of age. All levels of severity were included.
Measured: All patient had diagnosis of BPD documented from admission at level 4 NICU.
NICU Length of Stay
The length of stay at the level 4 NICU was compared between groups.
Measured: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
Three Year Development- Communication
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes. Scores are separated into on schedule, monitoring zone, and below cutoff. These thresholds vary by aged screened. Possible screens used for this age group include 36 months, 42 months, and 48 months dependent on exact chronologic age screen completed. At 36 months communication 45-60 is on schedule; 35-40 monitoring, and <35 below cutoff. For 42 months on schedule 40-60; monitoring 30-35; below cutoff <35. For 48 months on schedule 45-60; monitoring 35-40; below cutoff <35.
Measured: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
Three Year Development: Gross Motor
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcome, there are three possible scoring categories on schedule (normal), monitoring zone, below cutoff. Score thresholds by possible screens include: 36 months on schedule 50-60; monitoring 40-45; below cutoff <40. 42 months on schedule 50-60; monitoring 40-45; below cutoff <40. 48 months on schedule 45-60; monitoring 35-40; below cutoff <35.
Measured: three year chronological age 3 years and 0 days to 3 years and 364 days
Three Year Development: Fine Motor
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes with three scoring categories: on schedule (normal), monitoring zone, and below cutoff. These thresholds vary by each category and screening age. Based on the possible screens for chronological age the score categories are: 36 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 42 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 48 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff.
Measured: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Problem Solving
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three possible score categories: on schedule (normal), monitoring zone, and below cutoff. Category thresholds vary by outcome category and age of screen. There are three possible screens that were used for this population, chosen based on chronologic age. The score categories based on age are: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 40-60 on schdule; 30-35 monitoring; <30 below cutoff. 48 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff
Measured: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Personal Social
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three score categories possible including on schedule (normal), monitoring zone, and below cutoff. These thresholds vary based on outcome measure and age of screen completed. Screen used depends on chronological age at screen. Score thresholds for each age include: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 48 months: 40-60 on schedule; 30-40 monitoring; <30 below cutoff.
Measured: three year chronological age (3 years and 0 days to 3 years and 364 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start30 Nov 2018
- Primary completion28 Mar 2021
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cholestasis of Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Indiana 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles P.B. Vanderpool, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387579
- Sponsor's protocol ID
- 1708745276
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2017
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03387579
- Acronym / sponsor ID
- 1708745276
- Conditions
- Cholestasis of Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Posted 26 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
Detailed description
Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.
| Arm | Type | Receives |
|---|---|---|
| Smoflipid 20% | Experimental | Drug: Smoflipid 20% Lipid Emulsion for InjectionPatients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations. |
| Intralipid 20% Reduction | Experimental | Drug: Intralipid, 20% Intravenous EmulsionPatients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study. |
| Intralipid 20% Historic | Other | Drug: Intralipid, 20% Intravenous EmulsionPatients who retrospectively received soy-based lipid (Intralipid) at standard dosing of 2-3 g/kg/day were eligible for inclusion. Patients in this group were matched to prospective patients based on diagnosis, gestational age, and length of lipid therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Current weight less than 750 grams
- AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
- Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
- Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5 days of age, > 1.5 older than five days of age)
- Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
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 |
|---|---|---|
| Smoflipid 20% Lipid Emulsion for InjectionIntravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day | Drug | Smoflipid 20% |
| Intralipid, 20% Intravenous EmulsionAlso: Intralipid 20% ReductionIntravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day | Drug | Intralipid 20% Reduction |
| Intralipid, 20% Intravenous EmulsionAlso: Intralipid 20% HistoricIntravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day | Drug | Intralipid 20% Historic |
Primary outcome
Number of Participants With Cholestasis
Time frame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Cholestasis was defined as a direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart.
19 secondary outcomes
Weight Velocity
Time frame: Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity.
Length Velocity
Time frame: Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity.
Head Circumference (OFC) Velocity
Time frame: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
Average Total Calorie Intake
Time frame: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
Number of Patients With Enteral Autonomy at End of Study
Time frame: Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks.
Number of Patients With Essential Fatty Acid Deficiency (EFAD)
Time frame: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
AST Change Over Time
Time frame: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
ALT Change Over Time
Time frame: ALT measured at enrollment and every 2 weeks for max 12 weeks.
Alkaline Phosphatase Change Over Time
Time frame: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
Triglyceride Level Over Time
Time frame: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
Gamma Glutamyl Transferase (GGT) Over Time
Time frame: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
Number of Patients With Retinopathy of Prematurity
Time frame: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease
Time frame: All patient had diagnosis of BPD documented from admission at level 4 NICU.
NICU Length of Stay
Time frame: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
Three Year Development- Communication
Time frame: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
Three Year Development: Gross Motor
Time frame: three year chronological age 3 years and 0 days to 3 years and 364 days
Three Year Development: Fine Motor
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Problem Solving
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Personal Social
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smoflipid 20% Lipid Emulsion for Injection and Intralipid, 20% Intravenous Emulsion in people with Cholestasis of Parenteral Nutrition, run by Indiana University at 1 site in United States.
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 0 inclusion and 8 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 30 Jul 2025. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Cholestasis (time frame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.