CholestasisNCT01173159
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
A study testing Omegaven in people with Cholestasis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cholestasis
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2018
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females ages one month of age to 18 years of age
- Patients with intestinal failure on TPN
- Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
- Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
- Signed informed consent for use of Omegaven® obtained
Who cannot join
- Any of the contraindications to use of Omegaven®
- Impaired lipid metabolism (triglycerides >1000 mg/dL) while on
- 1g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
Show all 15Show fewer
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
- Females of child-bearing potential who are unwilling to use birth control during study participation
- Parental decision to forego the use of Omegaven®
- Known fish or egg allergy
- Pregnancy
- Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Read the detailed description
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
- Conditions
- Cholestasis
- Being tested
- Omegaven
- Keywords
- Parenteral Nutrition, Cholestasis
- Medical subject headings
- Cholestasis, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Experimental | Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in Conjugated/Direct Bilirubin
Change in conjugated/direct bilirubin level to below 1 mg/dl.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Secondary outcomes (6)
Number of Participants With a Change in Unconjugated/Total Bilirubin
Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Aspartate Transaminase (AST)
Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme (ALT)
Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Triglycerides
Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Measured: Completion of Therapy (time frame from 1-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2018
- Study completionDec 2018
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 CholestasisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Kocoshis, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173159
- Sponsor's protocol ID
- 2009-2314
- Status last verified
- Jun 2020
- First submitted
- 29 Jul 2010
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
- ClinicalTrials.gov ID
- NCT01173159
- Acronym / sponsor ID
- 2009-2314
- Conditions
- Cholestasis
- Keywords
- Parenteral Nutrition, Cholestasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Posted 8 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Detailed description
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
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: OmegavenSubjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females ages one month of age to 18 years of age
- Patients with intestinal failure on TPN
- Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
- Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
Key exclusion criteria (15 listed)
- Any of the contraindications to use of Omegaven®
- 1g/kg/day or less of Intralipid
- Parental decision to forego the use of Omegaven®
- Known fish or egg allergy
- Pregnancy
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 |
|---|---|---|
| OmegavenFor the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site. | Drug | Omegaven |
Primary outcome
Number of Participants With a Change in Conjugated/Direct Bilirubin
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Change in conjugated/direct bilirubin level to below 1 mg/dl.
6 secondary outcomes
Number of Participants With a Change in Unconjugated/Total Bilirubin
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Aspartate Transaminase (AST)
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme (ALT)
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Number of Participants With a Change in Triglycerides
Time frame: Completion of Therapy (time frame from 1-14 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Samuel Kocoshis, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Cholestasis, run by Children's Hospital Medical Center, Cincinnati 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 15 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 17 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 8 May 2020). 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?
Number of Participants With a Change in Conjugated/Direct Bilirubin (time frame: Completion of Therapy (time frame from 1-14 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 17 Jun 2020.