Trial · NCT02966834
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | Baseline and Week 16 | Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Baseline and at Week 16 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations \>=1.67 times ULN and/or total bilirubin concentrations \>ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed. | International units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | At Week 16 | Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Micromoles per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Grams per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Up to 12 weeks | Safety Population. It consisted of all randomized participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-SAEs and SAEs -Final Study Period | Up to 4 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Up to 4 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | At Weeks 8, 12, 16 and 20 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematology Data of Potential Clinical Importance | At Weeks 8, 12, 16 and 20 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | At Weeks 8, 12, 16 and 20 | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and Week 20 | Safety Population. Only those participants with data available at the specified data points were analyzed . | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate | Baseline and Week 20 | Safety Population. Only those participants with data available at the specified data points were analyzed. | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Baseline and Week 20 | Safety Population. Only those participants with data available at the specified data points were analyzed . | Scores on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT02966834/outcomes