Trial · NCT02010034
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
NCT02010034, Not applicable, Completed, Children's Medical Center Dallas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury. Trials, record NCT02010034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02010034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
- NCT number
- NCT02010034
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Children's Medical Center Dallas
- Conditions
- Liver Disease, Impaired Liver Function, Parenteral Nutrition Associated Liver Disease
- Interventions
- Omegaven
- First posted
- 2013-12-12
- Last updated
- 2019-02-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bilirubin in mg/dL | 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. |
| Secondary | Number of participants with adverse events | 12 weeks | a. 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. B. PN containing Omegaven will be safe for patients with respect to the risk of unexpected bleeding, coagulopathies, and other adverse events. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02010034
GET https://conductscience.org/api/trials/v1/NCT02010034/registered