Trial · NCT01325584
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
NCT01325584, Phase 2, Terminated, Midwestern Regional Medical Center; results first posted 2018-06-27
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 NCT01325584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01325584
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
- NCT01325584
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Midwestern Regional Medical Center
- Conditions
- Cancer, Hepatic Injury
- Interventions
- Omegaven
- First posted
- 2011-03-30
- Last updated
- 2018-08-07
- Results first posted
- 2018-06-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Conjugated Bilirubin | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | Highest detected lab values will be summarized between baseline and end of study participation. |
| Primary | Average Change in Alkaline Phosphatase | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | lab values will be summarized at baseline and as change from baseline to worst follow-up value. |
| Primary | Number of Patients Experiencing Adverse Events | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | The number of patients reporting or experiencing adverse effects will be reported. |
| Primary | Average Improvement in AST | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value. |
| Primary | Average Improvement in ALT | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Conjugated Bilirubin | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | mg/dl | MEAN | |
| PRIMARY | Average Change in Alkaline Phosphatase | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | Average Improvement in Alkaline Phosphatase | U/L | MEAN |
| PRIMARY | Number of Patients Experiencing Adverse Events | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Average Improvement in AST | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | U/L | MEAN | |
| PRIMARY | Average Improvement in ALT | Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks. | U/L | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Conjugated Bilirubin | Omegaven (Compassionate Use) | 1.0 | Standard Deviation 0.1 | mg/dl | |
| Average Change in Alkaline Phosphatase | Omegaven (Compassionate Use) | Baseline | 457.6 | Full Range 390 to 1006 | U/L |
| Average Change in Alkaline Phosphatase | Omegaven (Compassionate Use) | 4 Week Nadir | 360.4 | Full Range 193 to 723 | U/L |
| Number of Patients Experiencing Adverse Events | Omegaven (Compassionate Use) | 1 | Participants | ||
| Average Improvement in AST | Omegaven (Compassionate Use) | Baseline | 88.7 | Full Range 31 to 402 | U/L |
| Average Improvement in AST | Omegaven (Compassionate Use) | 4 Weeks Nadir | 69.9 | Full Range 24 to 160 | U/L |
| Average Improvement in ALT | Omegaven (Compassionate Use) | Baseline | 133.6 | Full Range 29 to 456 | U/L |
| Average Improvement in ALT | Omegaven (Compassionate Use) | 4 Weeks Nadir | 101.4 | Full Range 15 to 336 | U/L |
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 | Omegaven (Compassionate Use) | 12 | |
| Overall Study | COMPLETED | Omegaven (Compassionate Use) | 11 | |
| Overall Study | NOT COMPLETED | Omegaven (Compassionate Use) | 1 |
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 | Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Omegaven (Compassionate Use) | 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 | Omegaven (Compassionate Use) | 1 | 11 |
| Total, other adverse events | Omegaven (Compassionate Use) | 1 | 11 |
| Total, serious adverse events | Omegaven (Compassionate Use) | 0 | 11 |
Source ClinicalTrials.gov
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/NCT01325584
GET https://conductscience.org/api/trials/v1/NCT01325584/registered