Trial · NCT00059202
Trial of High-dose Urso in Primary Sclerosing Cholangitis
NCT00059202, Phase 2, Phase 3, Terminated, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of High-dose Urso in Primary Sclerosing Cholangitis. Trials, record NCT00059202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00059202
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of High-dose Urso in Primary Sclerosing Cholangitis
- NCT number
- NCT00059202
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Ursodeoxycholic Acid, Placebo
- First posted
- 2003-04-22
- Last updated
- 2021-05-03
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Failure | 5 years | Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis |
| Secondary | Number of Deaths | 5 years | Death at any time up to 5 years |
| Secondary | Number of Participants Who Have a Liver Transplantation | 5 years | Liver transplantation at any time up to 5 years |
| Secondary | Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation | 5 years | Meeting minimal listing criteria for liver transplantation at any time up to 5 years. Minimal listing criteria are defined as a MELD score of 14 or higher. The Model For End-Stage Liver Disease (MELD) is a numeric score with a range of 6 to 40, where a higher score means worse liver disease. |
| Secondary | Number of Participants Who Developed Cholangiocarcinoma | 5 years | Development of cholangiocarcinoma at any time up to 5 years |
| Secondary | Number of Participants Who Developed Varices | 5 years | Development of esophogeal and/or gastric varices |
| Secondary | Number of Participants Who Developed Cirrhosis | 5 years | Development of cirrhosis based on liver biopsy |
| Secondary | Alkaline Phosphatase at 12 Months | 12 months | Alkaline phosphatase divided by the upper limit of normal |
| Secondary | Alkaline Phosphatase at 24 Months | 24 months | Alkaline phosphatase divided by the upper limit of normal |
| Secondary | Alkaline Phosphatase at 36 Months | 36 months | Alkaline phosphatase divided by the upper limit of normal |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Treatment Failure | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Deaths | 5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Who Have a Liver Transplantation | 5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation | 5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Who Developed Cholangiocarcinoma | 5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Who Developed Varices | 5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Who Developed Cirrhosis | 5 years | participants | NUMBER | |
| SECONDARY | Alkaline Phosphatase at 12 Months | 12 months | Ratio | MEDIAN | |
| SECONDARY | Alkaline Phosphatase at 24 Months | 24 months | Ratio | MEDIAN | |
| SECONDARY | Alkaline Phosphatase at 36 Months | 36 months | Ratio | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
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 Treatment Failure | Ursodeoxycholic Acid | 30 | Participants | ||
| Number of Participants With Treatment Failure | Placebo | 19 | Participants | ||
| Number of Deaths | Ursodeoxycholic Acid | 5 | participants | ||
| Number of Deaths | Placebo | 3 | participants | ||
| Number of Participants Who Have a Liver Transplantation | Ursodeoxycholic Acid | 11 | participants | ||
| Number of Participants Who Have a Liver Transplantation | Placebo | 5 | participants | ||
| Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation | Ursodeoxycholic Acid | 13 | participants | ||
| Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation | Placebo | 10 | participants | ||
| Number of Participants Who Developed Cholangiocarcinoma | Ursodeoxycholic Acid | 2 | participants | ||
| Number of Participants Who Developed Cholangiocarcinoma | Placebo | 2 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ursodeoxycholic Acid | 76 | |
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | COMPLETED | Ursodeoxycholic Acid | 70 | |
| Overall Study | COMPLETED | Placebo | 59 | |
| Overall Study | NOT COMPLETED | Ursodeoxycholic Acid | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ursodeoxycholic Acid | 5 | 76 |
| Total, all-cause mortality | Placebo | 3 | 74 |
| Total, other adverse events | Ursodeoxycholic Acid | 0 | 76 |
| Total, other adverse events | Placebo | 0 | 74 |
| Total, serious adverse events | Ursodeoxycholic Acid | 0 | 76 |
| Total, serious adverse events | Placebo | 0 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19585548 | RESULT |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01DK056924 | Multicentered Randomized Trial of High-dose Urso in PSC | TALWALKAR, JAYANT A | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2001 to 2011 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ursodeoxycholic Acid vs Placebo: Number of Participants Who Developed Varices | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Participants With Treatment Failure | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Deaths | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Participants Who Developed Cholangiocarcinoma | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Participants Who Developed Cirrhosis | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: deaths from any cause | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: Number of Participants Who Have a Liver Transplantation | Trial comparisons |
| Ursodeoxycholic Acid vs Placebo: 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/NCT00059202
GET https://conductscience.org/api/trials/v1/NCT00059202/results?page=2