Trial · NCT01173159
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
NCT01173159, Not applicable, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis. Trials, record NCT01173159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01173159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
- NCT number
- NCT01173159
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Cholestasis
- Interventions
- Omegaven
- First posted
- 2010-07-30
- Last updated
- 2020-06-17
- Results first posted
- 2020-05-08
- Limitations and caveats
- We enrolled very few patients so that we have too small a cohort with which to assess achievement of our outcomes.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Change in Conjugated/Direct Bilirubin | Completion of Therapy (time frame from 1-14 weeks) | Change in conjugated/direct bilirubin level to below 1 mg/dl. |
| Secondary | Number of Participants With a Change in Unconjugated/Total Bilirubin | Completion of Therapy (time frame from 1-14 weeks) | Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
| Secondary | Number of Participants With a Change in Aspartate Transaminase (AST) | Completion of Therapy (time frame from 1-14 weeks) | Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
| Secondary | Number of Participants With a Change in Liver Enzyme (ALT) | Completion of Therapy (time frame from 1-14 weeks) | Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
| Secondary | Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase | Completion of Therapy (time frame from 1-14 weeks) | Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
| Secondary | Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) | Completion of Therapy (time frame from 1-14 weeks) | Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
| Secondary | Number of Participants With a Change in Triglycerides | Completion of Therapy (time frame from 1-14 weeks) | Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. |
Source ClinicalTrials.gov
Outcomes7
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 a Change in Conjugated/Direct Bilirubin | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Unconjugated/Total Bilirubin | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Aspartate Transaminase (AST) | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Liver Enzyme (ALT) | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Triglycerides | Completion of Therapy (time frame from 1-14 weeks) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
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 a Change in Conjugated/Direct Bilirubin | Omegaven | 4 | Participants | ||
| Number of Participants With a Change in Unconjugated/Total Bilirubin | Omegaven | 5 | Participants | ||
| Number of Participants With a Change in Aspartate Transaminase (AST) | Omegaven | 2 | Participants | ||
| Number of Participants With a Change in Liver Enzyme (ALT) | Omegaven | 1 | Participants | ||
| Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase | Omegaven | 3 | Participants | ||
| Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) | Omegaven | 0 | Participants | ||
| Number of Participants With a Change in Triglycerides | Omegaven | 8 | 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 | 10 | |
| Overall Study | COMPLETED | Omegaven | 10 | |
| Overall Study | NOT COMPLETED | Omegaven | 0 |
Source ClinicalTrials.gov
Adverse events37
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 | Vomiting | General disorders | Omegaven | 2 | 10 | 3 |
| other | Fever | General disorders | Omegaven | 3 | 10 | 6 |
| other | Upper Respiratory Infection | General disorders | Omegaven | 1 | 10 | 1 |
| other | Phosporus Decreased | Investigations | Omegaven | 1 | 10 | 1 |
| other | Skin Irritation and breakdown | Skin and subcutaneous tissue disorders | Omegaven | 2 | 10 | 2 |
| other | Diaper Dermatitis | Skin and subcutaneous tissue disorders | Omegaven | 1 | 10 | 1 |
| other | Pulmonary Vein Stenosis | Vascular disorders | Omegaven | 1 | 10 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Omegaven | 1 | 10 | 1 |
| other | Gastrointestinal Fistula | Gastrointestinal disorders | Omegaven | 2 | 10 | 2 |
| other | Blood in Stool | Gastrointestinal disorders | Omegaven | 1 | 10 | 1 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omegaven | 0 | 10 |
| Total, other adverse events | Omegaven | 6 | 10 |
| Total, serious adverse events | Omegaven | 4 | 10 |
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/NCT01173159
GET https://conductscience.org/api/trials/v1/NCT01173159/events?page=2