Trial · NCT00910104
Cholestasis Reversal: Efficacy of IV Fish Oil
NCT00910104, Phase 2, Phase 3, Completed, Mark Puder; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cholestasis Reversal: Efficacy of IV Fish Oil. Trials, record NCT00910104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cholestasis Reversal: Efficacy of IV Fish Oil
- NCT number
- NCT00910104
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Mark Puder
- Conditions
- Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
- Interventions
- Omegaven®
- First posted
- 2009-05-29
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. | Duration of treatment | Time to reversal of established parenteral nutrition associated liver disease, defined as a decrease in direct bilirubin to \<= 2.0 mg/dL. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. | Duration of treatment | The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \<= 2.0 mg/dL). | Weeks | MEDIAN |
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 |
|---|---|---|---|---|---|
| Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. | Omegaven | 11.7 | Inter-Quartile Range 7.7 to 13.9 | Weeks | |
| Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. | Intralipid (Historical Control) | 6.4 | Inter-Quartile Range 3.1 to 9.7 | Weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omegaven | 42 | |
| Overall Study | STARTED | Intralipid | 49 | |
| Overall Study | COMPLETED | Omegaven | 42 | |
| Overall Study | COMPLETED | Intralipid | 49 | |
| Overall Study | NOT COMPLETED | Omegaven | 0 | |
| Overall Study | NOT COMPLETED | Intralipid | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Hypertriglyceridemia | Investigations | Omegaven | 2 | 42 | 2 |
| other | Hypertriglyceridemia | Investigations | Intralipid | 12 | 49 | 56 |
| other | INR > 2.0 | Investigations | Omegaven | 3 | 42 | 9 |
| other | INR > 2.0 | Investigations | Intralipid | 5 | 49 | 24 |
| other | Essential fatty acid deficiency | Investigations | Omegaven | 2 | 42 | 3 |
| other | Essential fatty acid deficiency | Investigations | Intralipid | 0 | 49 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omegaven | 3 | 42 |
| Total, all-cause mortality | Intralipid | 12 | 49 |
| Total, other adverse events | Omegaven | 7 | 42 |
| Total, other adverse events | Intralipid | 17 | 49 |
| Total, serious adverse events | Omegaven | 0 | 42 |
| Total, serious adverse events | Intralipid | 0 | 49 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003460 | Cholestasis Reversal (Phase ll): Efficacy of lV Fish Oil | PUDER, MARK | BOSTON CHILDREN'S HOSPITAL | FOOD AND DRUG ADMINISTRATION | 2008 to 2010 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omegaven vs Intralipid: deaths from any cause | Trial comparisons |
| Omegaven vs Intralipid: serious adverse events | Trial comparisons |
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/NCT00910104
GET https://conductscience.org/api/trials/v1/NCT00910104/registered