Liver DiseaseNCT02010034
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
A study testing Omegaven in people with Liver Disease and Impaired Liver Function, run by Children's Medical Center Dallas at 1 site in United States.
Trial summary
This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth. Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Liver Disease, Impaired Liver Function, Parenteral Nutrition Associated Liver Disease
- What is being tested?
- Omegaven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 5 Feb 2019
- 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 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be 2 months -10 years of age
- Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of >2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
- 2 consecutive direct bilirubin test results >2.0mg/dl
- The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)
- Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of< 2, but who remain TPN dependent and require continued therapy with Omegaven
Who cannot join
- Other known 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, guardian, or child is unwilling to provide consent or assent
- Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
- Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
- Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
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- Unstable diabetes mellitus
- Stroke/embolism
- Collapse and shock
- Undefined coma status
- Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center of Dallas
Dallas, Texas, 75235
About this study
This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.
Read the detailed description
PAtients with direct bilirubin >2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.
- Being tested
- Omegaven
- Keywords
- TPN, Liver Function, parenteral nutritional fat emulsions
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Omegaven will be used in place of soy oil Intralipid
| Study group | Role | What they receive |
|---|---|---|
| Compassionate use | Other | This lipid preparation is only being used for compassionate use. Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin in mg/dL
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
- after reaching bilirubin levels >2mg/dl, subjects receiving Omegaven will reach a bilirubin level < 2mg/dL faster that patients receiving conventional fat emulsions.
Measured: 12 weeks
Secondary outcomes (1)
Number of participants with adverse events
- After starting Omegaven on PN, the rate of fatty acid deficiencies and imbalances will be as low as before Omegaven. Also, the rate of triglyceride events >400mg/dL with Omegaven will be similar to that seen with PN administration with soy oil Intralipid.
- PN containing Omegaven will be safe for patients with respect to the risk of unexpected bleeding, coagulopathies, and other adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startAug 2013
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Medical Center Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nandini Channabasappa, MD, Children's Medical Center Dallas
- Investigators
- Nandini Channabasappa, MD, Principal investigator, Childrens Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010034
- Sponsor's protocol ID
- STU 112010-159
- Status last verified
- Feb 2019
- First submitted
- 19 Aug 2013
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
- ClinicalTrials.gov ID
- NCT02010034
- Acronym / sponsor ID
- STU 112010-159
- Keywords
- TPN, Liver Function, parenteral nutritional fat emulsions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Children's Medical Center DallasUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 12 Dec 2013 (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 study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.
Detailed description
PAtients with direct bilirubin >2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassionate use | Other | Drug: OmegavenThis lipid preparation is only being used for compassionate use. |
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients must be 2 months -10 years of age
- Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of >2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
- 2 consecutive direct bilirubin test results >2.0mg/dl
- The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)
Key exclusion criteria (11 listed)
- Other known 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, guardian, or child is unwilling to provide consent or assent
- Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
- Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
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 will be used in place of soy oil Intralipid | Drug | Compassionate use |
Primary outcome
Bilirubin in mg/dL
Time frame: 12 weeks
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 1. after reaching bilirubin levels >2mg/dl, subjects receiving Omegaven will reach a bilirubin level < 2mg/dL faster that patients receiving conventional fat emulsions.
1 secondary outcome
Number of participants with adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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.
Nandini Channabasappa, MD principal investigator
Childrens Health
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 Liver Disease and Impaired Liver Function, run by Children's Medical Center Dallas 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 6 inclusion and 11 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 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bilirubin in mg/dL (time frame: 12 weeks). 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 6 Feb 2019.