CholestasisNCT02778698
Compassionate Use of Omegaven
A study testing Omegaven in people with Cholestasis, run by Geisinger Clinic.
Trial summary
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. Read more about this study
- Who is it for?
- Ages 15 days to 5 years
- Conditions the study is for
- Cholestasis
- What is being tested?
- Omegaven
- How many people
- Not given
- Where
- No sites listed yet
- 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 15 days to 5 years
- All sexes
- Child
Who may be able to join
- Male or female
- Older than 14 days and less than 5 years of age
- Direct bilirubin value is greater than 2 mg/dL
- Be expected to require intravenous nutrition for at least an additional 28 days
- Parent/legal guardian has agreed to provide consent/parental permission
Who cannot join
- Patients who have a congenitally lethal condition (e.g. Trisomy 13).
- Patients who have clinically severe bleeding not able to be managed with routine measures.
- Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
- Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
- 5 The parent/legal guardian is unwilling to provide consent/parental permission.
About this study
Official title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver.
It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.
Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.
- Conditions
- Cholestasis
- Being tested
- Omegaven
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Everett DO, Geisinger Clinic
- Investigators
- Edward A Everett, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778698
- Sponsor's protocol ID
- OMEGAVEN
- Status last verified
- Mar 2019
- First submitted
- 18 May 2016
- Last updated
- 12 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children
- ClinicalTrials.gov ID
- NCT02778698
- Acronym / sponsor ID
- OMEGAVEN
- Conditions
- Cholestasis
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- First posted
- 20 May 2016 (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.
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver.
It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.
Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.
Study design
Who may qualify
- Ages
- 15 days to 5 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female
- Older than 14 days and less than 5 years of age
- Direct bilirubin value is greater than 2 mg/dL
- Be expected to require intravenous nutrition for at least an additional 28 days
- Parent/legal guardian has agreed to provide consent/parental permission
Key exclusion criteria (5 listed)
- Patients who have a congenitally lethal condition (e.g. Trisomy 13).
- Patients who have clinically severe bleeding not able to be managed with routine measures.
- Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
- Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
- 5 The parent/legal guardian is unwilling to provide consent/parental permission.
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 |
|---|---|---|
| Omegaven | Dietary supplement | – |
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 12 Mar 2019.
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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.
Edward A Everett, DO principal investigator
Geisinger Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Omegaven in people with Cholestasis, run by Geisinger Clinic.
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 5 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 12 Mar 2019.