Trial · NCT01802073
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
NCT01802073, Phase 3, Completed, Stanford University; results first posted 2018-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects. Trials, record NCT01802073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01802073
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
- NCT number
- NCT01802073
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Oral Vancomycin
- First posted
- 2013-03-01
- Last updated
- 2018-09-21
- Results first posted
- 2018-09-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT was any value greater than the upper limit of the standard reference range used by patient's laboratory. |
| Primary | Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated GGT was any value greater than the upper limit of the standard reference range used by patient's laboratory. |
| Primary | Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT (and GGT) was any value greater than the upper limit of the standard reference range used by patient's laboratory. |
| Primary | Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis. |
| Primary | Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis). |
| Primary | Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Participants with ALT elevated at baseline are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Participants with GGT elevated at baseline are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 | Baseline; Month 3 | Participants with ALT and/or GGT elevated at baseline are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Participants with abnormal MRCP at baseline are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Participants with abnormal liver biopsy at baseline and who had a post-treatment liver biopsy are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1 | Baseline; Year 1 | Participants with abnormal MRCP and/or liver biopsy at baseline are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Children | 10 | Participants | ||
| Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Adults | 6 | Participants | ||
| Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Children | 8 | Participants | ||
| Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Adults | 6 | Participants | ||
| Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Children | 10 | Participants | ||
| Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 | Oral Vancomycin-Adults | 8 | Participants | ||
| Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 | Oral Vancomycin-Children | 6 | Participants | ||
| Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 | Oral Vancomycin-Adults | 4 | Participants | ||
| Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 | Oral Vancomycin-Children | 3 | Participants | ||
| Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 | Oral Vancomycin-Adults | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Vancomycin-Children | 14 | |
| Overall Study | STARTED | Oral Vancomycin-Adults | 20 | |
| Overall Study | COMPLETED | Oral Vancomycin-Children | 9 | |
| Overall Study | COMPLETED | Oral Vancomycin-Adults | 9 | |
| Overall Study | NOT COMPLETED | Oral Vancomycin-Children | 5 | |
| Overall Study | NOT COMPLETED | Oral Vancomycin-Adults | 11 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Biliary stricture requiring stent | Hepatobiliary disorders | Oral Vancomycin-Children | 1 | 14 | |
| serious | Biliary stricture requiring stent | Hepatobiliary disorders | Oral Vancomycin-Adults | 0 | 20 | |
| serious | Progression of PSC | Hepatobiliary disorders | Oral Vancomycin-Children | 1 | 14 | |
| serious | Progression of PSC | Hepatobiliary disorders | Oral Vancomycin-Adults | 0 | 20 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Vancomycin-Children | 0 | 14 |
| Total, all-cause mortality | Oral Vancomycin-Adults | 0 | 20 |
| Total, other adverse events | Oral Vancomycin-Children | 0 | 14 |
| Total, other adverse events | Oral Vancomycin-Adults | 0 | 20 |
| Total, serious adverse events | Oral Vancomycin-Children | 1 | 14 |
| Total, serious adverse events | Oral Vancomycin-Adults | 0 | 20 |
Source ClinicalTrials.gov
Papers2
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 | Trial comparisons |
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1 | Trial comparisons |
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 | Trial comparisons |
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 | Trial comparisons |
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: deaths from any cause | Trial comparisons |
Oral Vancomycin-Children vs Oral Vancomycin-Adults: Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 | Trial comparisons |
| Oral Vancomycin-Children vs Oral Vancomycin-Adults: 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/NCT01802073
GET https://conductscience.org/api/trials/v1/NCT01802073/registered