Total Parenteral Nutrition-induced CholestasisPhase 2/3NCT02370251
Compassionate Use of Omegaven in Children
A Phase 2/3 study testing Omegaven in people with Total Parenteral Nutrition-induced Cholestasis and Cholestasis, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome
- What is being tested?
- Omegaven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 27 Sep 2019
- Phase
- Phase 2/3
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Live in or temporarily relocate to Oklahoma
- Age less than 18 years, both sexes, all races
- Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
- Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
- Are not currently enrolled in another lipid emulsion study
Who cannot join
- Known food allergy to fish
- Known metabolic disorder of lipid metabolism
- Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
- Medical condition likely to result in death in the next 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Children's Hospital
Oklahoma City, Oklahoma, 73104
About this study
Official title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Read the detailed description
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases
- Being tested
- Omegaven
- Keywords
- Fat Emulsions, Intravenous, Parenteral-Nutrition-Associated Liver Disease, Cholestasis, Omegaven, Fish Oil
- Medical subject headings
- Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Also called Fish oil-based lipid, Omega-3-fatty acid lipid emulsion
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Experimental | Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm. Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Cholestasis for Subjects Who Received Omegaven
To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)
Measured: Within the first 3 months of sole Omegaven use
Secondary outcomes (2)
Safety Issues for Infants Who Received Omegaven
To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death
Measured: Within the first year of use
Essential Fatty Acid Deficiency in Infants Who Received Omegaven
To determine if Omegaven can resolve essential fatty acid deficiency
Measured: Within the first month of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startJun 2015
- Primary completion27 Sep 2018
- Study completion27 Sep 2019
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 Total Parenteral Nutrition-induced CholestasisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- OU Medical Center
- Responsible party
- Sponsor
- Investigators
- Kimberly D Ernst, MD, MSMI, Principal investigator, The University of Oklahoma, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370251
- Sponsor's protocol ID
- 5451
- Status last verified
- Nov 2019
- First submitted
- 17 Feb 2015
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
- ClinicalTrials.gov ID
- NCT02370251
- Acronym / sponsor ID
- 5451
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases
- Keywords
- Fat Emulsions, Intravenous, Parenteral-Nutrition-Associated Liver Disease, Cholestasis, Omegaven, Fish Oil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- OU Medical Center
- Study start
- Jun 2015 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Detailed description
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omegaven | Experimental | Drug: OmegavenChildren will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Live in or temporarily relocate to Oklahoma
- Age less than 18 years, both sexes, all races
- Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
- Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
- Are not currently enrolled in another lipid emulsion study
Key exclusion criteria (4 listed)
- Known food allergy to fish
- Known metabolic disorder of lipid metabolism
- Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
- Medical condition likely to result in death in the next 30 days
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 |
|---|---|---|
| OmegavenAlso: Fish oil-based lipid, Omega-3-fatty acid lipid emulsionOnce the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs. | Drug | Omegaven |
Primary outcome
Resolution of Cholestasis for Subjects Who Received Omegaven
Time frame: Within the first 3 months of sole Omegaven use
To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)
2 secondary outcomes
Safety Issues for Infants Who Received Omegaven
Time frame: Within the first year of use
Essential Fatty Acid Deficiency in Infants Who Received Omegaven
Time frame: Within the first month of use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Kimberly D Ernst, MD, MSMI principal investigator
The University of Oklahoma, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omegaven in people with Total Parenteral Nutrition-induced Cholestasis and Cholestasis, run by University of Oklahoma 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 5 inclusion and 4 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 25 Nov 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Nov 2019). 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?
Resolution of Cholestasis for Subjects Who Received Omegaven (time frame: Within the first 3 months of sole Omegaven use). 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 25 Nov 2019.