Trial · NCT01845116
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
NCT01845116, Phase 2, Completed, Wake Forest University Health Sciences; results first posted 2022-11-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury. Trials, record NCT01845116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01845116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
- NCT number
- NCT01845116
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Total Parenteral Nutrition-induced Cholestasis
- Interventions
- Omegaven®
- First posted
- 2013-05-03
- Last updated
- 2022-11-23
- Results first posted
- 2022-11-23
- Limitations and caveats
The last patient enrolled in the study was on 11/8/2016. Due to decreased enrollment permission was granted by the Atrium Health IRB to officially close the study to new enrollees on May 31, 2019. The last patient enrolled is now 5 years removed from enrollment date.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Normalization of Direct Bilirubin | Month 9 | Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months. This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease. |
| Secondary | Number of Participants With Normal Essential Fatty Acid (EFA) Profiles. | Months 1 through 9 | EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is \> 0.2). Collected monthly from month 1-9. |
| Secondary | Number of Participants With Triglyceride Levels > 400 mg/dL | baseline data and then weekly and monthly evaluations, for an average of 9 months | Number of participants with triglyceride levels \> 400 mg/dL |
| Secondary | Number of Participants With Unexpected Bleeding or Coagulopathies | Month 6 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Normalization of Direct Bilirubin | Month 9 | participants | NUMBER | |
| SECONDARY | Number of Participants With Normal Essential Fatty Acid (EFA) Profiles. | Months 1 through 9 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Triglyceride Levels > 400 mg/dL | baseline data and then weekly and monthly evaluations, for an average of 9 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Unexpected Bleeding or Coagulopathies | Month 6 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Normalization of Direct Bilirubin | Single Arm | 11 | participants | ||
| Number of Participants With Normal Essential Fatty Acid (EFA) Profiles. | Single Arm | 10 | Participants | ||
| Number of Participants With Triglyceride Levels > 400 mg/dL | Single Arm | 0 | Participants | ||
| Number of Participants With Unexpected Bleeding or Coagulopathies | Single Arm | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm | 11 | |
| Overall Study | COMPLETED | Single Arm | 11 | |
| Overall Study | NOT COMPLETED | Single Arm | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Essential fatty acid deficiency | Metabolism and nutrition disorders | Single Arm | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | 0 | 11 |
| Total, other adverse events | Single Arm | 1 | 11 |
| Total, serious adverse events | Single Arm | 0 | 11 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01845116
GET https://conductscience.org/api/trials/v1/NCT01845116/registered