Parenteral Nutrition Associated Liver DiseaseNCT02121769
Omegaven Expanded Access Protocol
A study testing Omegaven in people with Parenteral Nutrition Associated Liver Disease, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.
Trial summary
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Parenteral Nutrition Associated Liver Disease
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Up to 17 years
- All sexes
- Child
Who may be able to join
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- Failed standard/conventional therapies to prevent progression of PNALD.
- Age newborn to 17 years of age
- Signed informed consent.
Who cannot join
- Allergy to eggs and/or shellfish
- Female who is pregnant or lactating
- Severe hemorrhagic disorder
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
- 18 years of age or older
- Parent/legally authorized representative is unwilling to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Pediatric Gastroenterology
Boise, Idaho, 83712
About this study
Official title: Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.
- Being tested
- Omegaven
- Keywords
- cholestasis, short bowel syndrome
- Medical subject headings
- Cholestasis, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral Nutrition Associated Liver DiseaseStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- St. Luke's Health System, Boise, Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Burpee, MD, St. Luke's Health System, Boise, Idaho
- Investigators
- Tyler Burpee, MD, Principal investigator, Pediatric Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121769
- Sponsor's protocol ID
- Omegaven Expanded Access
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2014
- Last updated
- 10 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375
- ClinicalTrials.gov ID
- NCT02121769
- Acronym / sponsor ID
- Omegaven Expanded Access
- Keywords
- cholestasis, short bowel syndrome
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- St. Luke's Health System, Boise, IdahoUniversity, hospital or other
- First posted
- 24 Apr 2014 (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.
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.
Study design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- Failed standard/conventional therapies to prevent progression of PNALD.
- Age newborn to 17 years of age
- Signed informed consent.
Key exclusion criteria (6 listed)
- Allergy to eggs and/or shellfish
- Female who is pregnant or lactating
- Severe hemorrhagic disorder
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
- 18 years of age or older
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 |
|---|---|---|
| Omegaven10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Related trials for Parenteral Nutrition Associated Liver Disease
RecruitingObservational study
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
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.
Tyler Burpee, MD principal investigator
Pediatric Gastroenterology
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 Parenteral Nutrition Associated Liver Disease, run by St. Luke's Health System, Boise, Idaho 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 6 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 10 Apr 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 10 Apr 2019.