CholestasisNCT02334293
Omegaven® as Parenteral Nutrition
A study testing Omegaven in people with Cholestasis, run by Carle Foundation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of… Read more about this study
- Who is it for?
- Ages 14 days to 4 months
- Conditions the study is for
- Cholestasis
- What is being tested?
- Omegaven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2017
- Phase
- Interventional
- 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 14 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Greater than 14 days old.
- Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4.
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.
- Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).
- Signed patient informed consent.
- The patient is expected to have a reasonable possibility of survival.
- No other known etiology of cholestasis other than PNALD at time of Omegaven® initiation.
Who cannot join
- Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to Omegaven® initiation.
- Known fish or egg allergy
- Any of the contraindications to use of Omegaven®:
- Active new infection at the time of initiation of Omegaven®
- Hemodynamic instability
- Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)
Show all 18Show fewer
- Active coagulopathy or bleeding
- Thrombocytopenia
- Unstable hyperglycemia
- Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
- Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian of child is unwilling to provide consent or assent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carle Foundation Hospital
Urbana, Illinois, 61801
217-326-0058, clinicaltrials@carle.com
William Stratton, MD
About this study
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.
- Conditions
- Cholestasis
- Being tested
- Omegaven
- Keywords
- Omegaven, parenteral nutrition, liver disease, liver injury
- Medical subject headings
- Cholestasis, Hyperphagia, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Other | Not described Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)
Primary efficacy analysis will include time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN).
Measured: Until weaned from PN
Secondary outcomes (2)
Growth (weight three times per week, length once weekly, and head circumference)
At a minimum, monitoring of growth parameters while on Omegaven® will include weight three times per week, length once weekly, and head circumference once weekly.
Measured: Until weaned from PN
Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)
We will monitor infants who are not receiving any enteral feeding at all for more than 4 weeks for any evidence of essential fatty acid (EFA) deficiency.
Measured: Until weaned from PN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholestasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carle Foundation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Stratton, MD, Principal investigator, Carle Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334293
- Sponsor's protocol ID
- 13055
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2015
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omegaven® as Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02334293
- Acronym / sponsor ID
- 13055
- Conditions
- Cholestasis
- Keywords
- Omegaven, parenteral nutrition, liver disease, liver injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Carle Foundation HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2017 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- 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.
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omegaven | Other | Drug: Omegaven |
Who may qualify
- Ages
- 14 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Greater than 14 days old.
- Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4.
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.
- Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).
- Signed patient informed consent.
Key exclusion criteria (18 listed)
- Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to Omegaven® initiation.
- Known fish or egg allergy
- Any of the contraindications to use of Omegaven®:
- Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian of child is unwilling to provide consent or assent
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 |
|---|---|---|
| OmegavenOmegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury. | Drug | Omegaven |
Primary outcome
Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)
Time frame: Until weaned from PN
Primary efficacy analysis will include time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN).
2 secondary outcomes
Growth (weight three times per week, length once weekly, and head circumference)
Time frame: Until weaned from PN
Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)
Time frame: Until weaned from PN
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
William Stratton, MD principal investigator
Carle Foundation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omegaven in people with Cholestasis, run by Carle Foundation Hospital 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 8 Jan 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deveine Toney ((217) 326-4504, deveine.toney@carle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN) (time frame: Until weaned from PN). 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 8 Jan 2015.