CholestasisNCT02148146
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
A study testing Omegaven in people with Cholestasis, run by University of California, San Diego at 2 sites in United States.
Trial summary
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cholestasis
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 2 sitesUnited 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18 years old
- 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, may be inpatient or outpatient
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
- Direct bilirubin > 2.0 mg/dl
- Signed patient informed consent
- The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)
Who cannot join
- Pregnancy
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian or child unwilling to provide consent or assent
- Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:
- Impaired lipid metabolism
Show all 12Show fewer
- Severe hemorrhagic disorders
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/embolism
- Recent cardiac infarction
- Undefined coma status
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego Medical Center
San Diego, California, 92037
Rady Children's Hospital of San Diego
San Diego, California, 92123
About this study
Official title: Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
Read the detailed description
Specific Aims of Study
- To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
- To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.
- Conditions
- Cholestasis
- Being tested
- Omegaven
- Keywords
- short bowel syndrome, intestinal failure, total parenteral nutrition associated cholestasis
- Medical subject headings
- Cholestasis, Short Bowel Syndrome, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Fish oil emulsion given 1g/kg/day as infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (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.
- More trials run by University of California, San DiegoThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lazar, MPH, Principal investigator, UC San Diego Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148146
- Sponsor's protocol ID
- 105591
- Status last verified
- Jan 2021
- First submitted
- 20 May 2014
- Last updated
- 12 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
- ClinicalTrials.gov ID
- NCT02148146
- Acronym / sponsor ID
- 105591
- Conditions
- Cholestasis
- Keywords
- short bowel syndrome, intestinal failure, total parenteral nutrition associated cholestasis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- First posted
- 28 May 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.
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
Detailed description
Specific Aims of Study
- To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
- To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.
Study design
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age < 18 years old
- 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, may be inpatient or outpatient
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
- Direct bilirubin > 2.0 mg/dl
- Signed patient informed consent
Key exclusion criteria (12 listed)
- Pregnancy
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian or child unwilling to provide consent or assent
- Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:
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 |
|---|---|---|
| OmegavenFish oil emulsion given 1g/kg/day as infusion | 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 12 Jan 2021.
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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.
Sarah Lazar, MPH principal investigator
UC San Diego Medical Center
2 sites 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 University of California, San Diego at 2 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 12 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 Jan 2021.