Total Parenteral Nutrition-induced CholestasisNCT01323907
Compassionate Use of Omegaven IV Fat Emulsion
A study testing Omegaven IV lipid emulsion in people with Total Parenteral Nutrition-induced Cholestasis, run by Sivan Kinberg at 1 site in United States.
Trial summary
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Total Parenteral Nutrition-induced Cholestasis
- What is being tested?
- Omegaven IV lipid emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 13 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of life threatening PNALD
- Dependent on Parenteral Nutrition for caloric needs
- Expected to require PN for at least another 30 days
- Other causes of liver disease have been excluded
- GI/Liver service is involved in patient care
- Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
- Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
- Must be at least 2 months of age
Who cannot join
- Not inpatient
- Younger than 2 months of age
- Expected to be weaned off of parenteral nutrition within 30 days
- have other documented causes of liver disease
- have signs of proven severe advanced liver disease
- Allergy to seafood, egg protein and/or previous allergy to Omegaven
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- active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
- must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
- Parent or legal guardian must be willing to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Presbyterian Medical Center-Children's Hospital of NY
New York, New York, 10032
About this study
Official title: Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.
- Being tested
- Omegaven IV lipid emulsion
- Keywords
- Total Parenteral Nutrition-induced Cholestasis, Omegaven, liver disease, Cholestasis, Fat emulsions
- Medical subject headings
- Liver Diseases, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven IV lipid emulsionDrug
Also called Omega-3 Fatty Acids
For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Experimental | Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease Receives: Drug: Omegaven IV lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of direct serum bilirubin level (mg/dL)
For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.
Measured: Up to 6 months from the completion of the study.
Secondary outcomes (1)
Essential fatty acid profile
Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.
Measured: Up to 30 days from therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startJan 2011 (estimated)
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Why it stopped: Omegaven is now FDA approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Parenteral Nutrition-induced 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sivan Kinberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sivan Kinberg, Columbia University
- Investigators
- Sivan Kinberg, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323907
- Sponsor's protocol ID
- AAAF2546
- Status last verified
- Feb 2020
- First submitted
- 16 Mar 2011
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
- ClinicalTrials.gov ID
- NCT01323907
- Acronym / sponsor ID
- AAAF2546
- Keywords
- Total Parenteral Nutrition-induced Cholestasis, Omegaven, liver disease, Cholestasis, Fat emulsions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Omegaven is now FDA approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sivan KinbergUniversity, hospital or other
- Study start
- Jan 2011 (estimated)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 28 Mar 2011 (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.
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.
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: Omegaven IV lipid emulsionOmegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of life threatening PNALD
- Dependent on Parenteral Nutrition for caloric needs
- Expected to require PN for at least another 30 days
- Other causes of liver disease have been excluded
- GI/Liver service is involved in patient care
Key exclusion criteria (9 listed)
- Not inpatient
- Younger than 2 months of age
- Expected to be weaned off of parenteral nutrition within 30 days
- have other documented causes of liver disease
- have signs of proven severe advanced liver disease
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 IV lipid emulsionAlso: Omega-3 Fatty AcidsFor infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition. | Drug | Omegaven |
Primary outcome
Reduction of direct serum bilirubin level (mg/dL)
Time frame: Up to 6 months from the completion of the study.
For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.
1 secondary outcome
Essential fatty acid profile
Time frame: Up to 30 days from therapy completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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.
Sivan Kinberg, MD, MS principal investigator
Columbia University
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 IV lipid emulsion in people with Total Parenteral Nutrition-induced Cholestasis, run by Sivan Kinberg 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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 6 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction of direct serum bilirubin level (mg/dL) (time frame: Up to 6 months from the completion of the study.). 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 2020.