Parenteral Nutrition Associated CholestasisPhase 1/2NCT01601652
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
A Phase 1/2 study testing Omegaven in people with Parenteral Nutrition Associated Cholestasis, run by Arthur J De Lorimier at 1 site in United States.
Trial summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Parenteral Nutrition Associated 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2018
- Phase
- Phase 1/2
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cholestasis defined as either
- serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
- serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Who cannot join
- Age > 1y at time that omegaven is started
- Not expected to survive at least 30 days
- Fish allergy in a first degree relative
- Hemodynamic instability
- Coagulopathy
- Not likely to require PN for > 30d
- Not expected to survive > 30d
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Being tested
- Omegaven
- Keywords
- cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
1 g/kg/d iv infusion over 24h
| Study group | Role | What they receive |
|---|---|---|
| Omeagven | Experimental | Not described Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Measured: approximately for 4 months
Secondary outcomes (1)
Liver Transaminases
Measured: approximately for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startNov 2011
- 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 Parenteral Nutrition Associated 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthur J De Lorimier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arthur J De Lorimier, University of California, Davis
- Investigators
- Ian J Griffin, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601652
- Sponsor's protocol ID
- 225576
- Other IDs
- UCD#225576-3
- Status last verified
- Jan 2021
- First submitted
- 9 May 2012
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
- ClinicalTrials.gov ID
- NCT01601652
- Acronym / sponsor ID
- 225576
- Keywords
- cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arthur J De LorimierUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omeagven | Experimental | Drug: Omegaven |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cholestasis defined as either
- serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
- serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Key exclusion criteria (7 listed)
- Age > 1y at time that omegaven is started
- Not expected to survive at least 30 days
- Fish allergy in a first degree relative
- Hemodynamic instability
- Coagulopathy
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 |
|---|---|---|
| Omegaven1 g/kg/d iv infusion over 24h | Drug | Omeagven |
Primary outcome
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Time frame: approximately for 4 months
1 secondary outcome
Liver Transaminases
Time frame: approximately for 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Parenteral Nutrition Associated Cholestasis
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
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.
Ian J Griffin, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omegaven in people with Parenteral Nutrition Associated Cholestasis, run by Arthur J De Lorimier 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 3 inclusion and 7 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 27 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). 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?
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) (time frame: approximately for 4 months). 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 27 Jan 2021.