Trial · NCT00826020
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
NCT00826020, Phase 2, Completed, University of Nebraska; results first posted 2019-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis. Trials, record NCT00826020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826020
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
- NCT number
- NCT00826020
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
- Interventions
- Omegaven™
- First posted
- 2009-01-21
- Last updated
- 2023-10-05
- Results first posted
- 2019-10-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Progression to Small Bowel Transplantation. | Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort | Whether or not the subject had an intestine-containing transplant or not |
| Secondary | Number of Subjects With Reversal of Biochemical Cholestasis | weekly x 4, then bi-weekly x4, then monthly until the completion of the study, with an average follow-up of 5.5 years for the study cohort | Of patients starting with elevated total serum bilirubin, the number that progress to normalization of serum total bilirubin in routine bloodwork |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Progression to Small Bowel Transplantation. | Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects With Reversal of Biochemical Cholestasis | weekly x 4, then bi-weekly x4, then monthly until the completion of the study, with an average follow-up of 5.5 years for the study cohort | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Progression to Small Bowel Transplantation. | Omegaven™ | 19 | Participants | ||
| Number of Subjects With Reversal of Biochemical Cholestasis | Omegaven™ | 56 | 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 | Omegaven™ | 72 | |
| Overall Study | COMPLETED | Omegaven™ | 72 | |
| Overall Study | NOT COMPLETED | Omegaven™ | 0 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omegaven™ | 7 | 72 |
| Total, other adverse events | Omegaven™ | 0 | 72 |
| Total, serious adverse events | Omegaven™ | 0 | 72 |
Source ClinicalTrials.gov
Papers6
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/NCT00826020
GET https://conductscience.org/api/trials/v1/NCT00826020/registered