Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 DaysPhase 3NCT02579265
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
A Phase 3 study testing Smoflipid 20% (investigational lipid for parenteral nutrition) and Intralipid® 20% in people with Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days, run by Fresenius Kabi at 13 sites in United States.
Trial summary
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample. Read more about this study
- Who is it for?
- Ages 0 weeks and older
- Conditions the study is for
- Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
- What is being tested?
- Smoflipid 20% (investigational lipid for parenteral nutrition) and Intralipid® 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2015to 10 Apr 2020
- 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 0 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates and infants, expected to require parenteral nutrition (PN) for 28 days
- Postmenstrual age ≥ 24 weeks
- Birth weight ≥ 750g
- Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
- At least 80% of nutritional needs at baseline received by PN
- Signed and dated informed consent obtained from at least one parent or legal guardian
Who cannot join
- Conjugated bilirubin > 0.6 mg/dL
- Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels > 0.6, mg/dL during study participation
- Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
- Active bloodstream infection demonstrated by positive blood culture at screening
- Cystic fibrosis
- Meconium ileus
Show all 16Show fewer
- Serum triglyceride levels > 250 mg/dL
- Cyanotic congenital heart defect
- Severe renal failure with serum creatinine > 2.0 mg/dL
- History of shock requiring vasopressors
- Anasarca
- Extracorporeal Membrane Oxygenation (ECMO)
- Known inborn errors of metabolism
- Known congenital viral infection
- Unlikely to survive longer than 28 days
- Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
Texas Children's Hospital
Houston, Texas, 77030
Vanderbilt Children's Hospital
Nashville, Tennessee, 37345
Yale - New Haven Children's Hospital
New Haven, Connecticut, 06510
Mount Sinai Hospital
New York, New York, 10029
Steven & Alexandra Cohen Children's Medical Center of NY
New York, New York, 11040
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1205
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
UC San Diego Medical Center
San Diego, California, 92103
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
Official title: A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
- Being tested
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Keywords
- Parenteral nutrition, Neonates, Infants, Lipid emulsions, Intravenous
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoflipid 20% (investigational lipid for parenteral nutrition)Drug
Also called Smoflipid 20% (lipid injectable emulsion)
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
Intralipid® 20%Drug
Also called Intralipid® 20% (a 20% intravenous fat emulsion)
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
| Study group | Role | What they receive |
|---|---|---|
| Smoflipid 20% | Experimental | Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Receives: Drug: Smoflipid 20% (investigational lipid for parenteral nutrition) |
| Intralipid® 20% | Active comparator | Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Receives: Drug: Intralipid® 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
Measured: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl
Secondary outcomes (15)
Body Weight (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Measured: Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)
Body Length (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Measured: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Head Circumference (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Measured: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Time to Full Enteral or Oral Feeds
Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds.
Measured: Day 29/end of treatment, if continued: Day 85/end of treatment
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC refers to red blood cells. Timepoints >10% of Subjects (overall) are displayed.
Measured: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Length of Stay in Hospital
Length of stay in hospital (time from randomization to discharge) was be calculated.
NA=Not available
Measured: Day 1- Follow up (7 days after end of treatment)
Ratio of Independent Bloodstream Infections to Number of Days on Study Medication
The Ratio is the incidence of bloodstream infection by numbers of day on study medication.
Measured: Day 1-29 or -85 if continued + Follow-up
Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication
Measured: Day 1-29 or -85 if continued + Follow-up
Number of Patients Who Complete PN Treatment Without Lipid Minimization
The Analysis was conducted over all study phases.
Measured: Day 1-29 or -85 if continued + Follow-up
Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels
Measured: Day 1-29 or -85 if continued + Follow-up
Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study
The area under the curve (AUC>1.5) is defined as the area between conjugated bilirubin concentrations > 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are >1.5 mg/dL
Measured: Day 1-29 or -85 if continued + Follow-up
Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization
The Analysis was performed over the entire study period.
Measured: Day 1-29 or -85 if continued + Follow-up
Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)
Measured: Day 1-29 or -85 if continued + Follow-up
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Measured: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Holman Index
Essential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of > 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with >10% of patients are displayed.
Measured: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion3 Apr 2020
- Study completion10 Apr 2020
Why it stopped: Outcome of a planned interim analysis was that the sample size required to show superiority was too high to be feasible. Fresenius Kabi requested termination to the FDA on 17 Jan 2020. FDA accepted termination by written response on 16 Apr 2020.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 DaysStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven A Abrams, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579265
- Sponsor's protocol ID
- SMOF-018-CP3
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2015
- Last updated
- 5 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.
PubMed 39374788
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02579265
- Acronym / sponsor ID
- SMOF-018-CP3
- Keywords
- Parenteral nutrition, Neonates, Infants, Lipid emulsions, Intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Outcome of a planned interim analysis was that the sample size required to show superiority was too high to be feasible. Fresenius Kabi requested termination to the FDA on 17 Jan 2020. FDA accepted termination by written response on 16 Apr 2020.
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 5 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoflipid 20% | Experimental | Drug: Smoflipid 20% (investigational lipid for parenteral nutrition)Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". |
| Intralipid® 20% | Active comparator | Drug: Intralipid® 20%Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". |
Who may qualify
- Ages
- 0 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Neonates and infants, expected to require parenteral nutrition (PN) for 28 days
- Postmenstrual age ≥ 24 weeks
- Birth weight ≥ 750g
- Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
- At least 80% of nutritional needs at baseline received by PN
Key exclusion criteria (16 listed)
- Conjugated bilirubin > 0.6 mg/dL
- Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels > 0.6, mg/dL during study participation
- Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
- Active bloodstream infection demonstrated by positive blood culture at screening
- Cystic fibrosis
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% (investigational lipid for parenteral nutrition)Also: Smoflipid 20% (lipid injectable emulsion)Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein. | Drug | Smoflipid 20% |
| Intralipid® 20%Also: Intralipid® 20% (a 20% intravenous fat emulsion)Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein. | Drug | Intralipid® 20% |
Primary outcome
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
Time frame: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
15 secondary outcomes
Body Weight (Change From Baseline)
Time frame: Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)
Body Length (Change From Baseline)
Time frame: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Head Circumference (Change From Baseline)
Time frame: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Time to Full Enteral or Oral Feeds
Time frame: Day 29/end of treatment, if continued: Day 85/end of treatment
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Length of Stay in Hospital
Time frame: Day 1- Follow up (7 days after end of treatment)
Ratio of Independent Bloodstream Infections to Number of Days on Study Medication
Time frame: Day 1-29 or -85 if continued + Follow-up
Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication
Time frame: Day 1-29 or -85 if continued + Follow-up
Number of Patients Who Complete PN Treatment Without Lipid Minimization
Time frame: Day 1-29 or -85 if continued + Follow-up
Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels
Time frame: Day 1-29 or -85 if continued + Follow-up
Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study
Time frame: Day 1-29 or -85 if continued + Follow-up
Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization
Time frame: Day 1-29 or -85 if continued + Follow-up
Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)
Time frame: Day 1-29 or -85 if continued + Follow-up
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Holman Index
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39374788Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.
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.
Steven A Abrams, MD principal investigator
University of Texas at Austin
13 sites 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% (investigational lipid for parenteral nutrition) and Intralipid® 20% in people with Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days, run by Fresenius Kabi at 13 sites 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 5 Jan 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?
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample (time frame: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl). 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 NCT02579265, which also lists 1 linked publication.
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 Jan 2022.