Trial · NCT03226067
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent Change in Serum GGT. | Baseline to week 24 (visit 7) | Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L) |
| Secondary | Absolute Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum GGT from baseline to each assessment. |
| Secondary | Percent Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum GGT from baseline to each assessment (serum GGT was measured in U/L) |
| Secondary | Percent Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum ALP from baseline to each assessment (serum ALP was measured in U/L). |
| Secondary | Absolute Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum ALP from baseline to each assessment. |
| Secondary | Absolute Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum conjugated bilirubin from baseline to each assessment. |
| Secondary | Percent Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum Conjugated bilirubin, from baseline to each assessment (serum conjugated bilirubin is measured in μmol/L). |
| Secondary | Absolute Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum total bilirubin, from baseline to each assessment. |
| Secondary | Percent Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in Serum Total Bilirubin from baseline to each assessment (serum total bilirubin is measured in μmol/L). |
| Secondary | Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Absolute change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24. |
| Secondary | Percent Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Percent change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa). |
| Secondary | Percent Change in Serum Levels of Collagen Fragments Indicative of Collagen Formation and Degradation. | From baseline to Weeks 12 and 24. | Percent change in serum levels of collagen fragments indicative of collagen formation and degradation, from baseline to Weeks 12 and 24 (serum levels of collagen fragments are measured in ng/mL). |
| Secondary | Absolute Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Absolute change in liver stiffness by subgroup (\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24. |
| Secondary | Percent Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Percent change in liver stiffness by subgroup (\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa). |
| Secondary | Absolute Change in Pruritis Visual Analogue Scale (VAS) Scores | From baseline to Weeks 12 and 24 | Absolute Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch. |
| Secondary | Percent Change in Pruritis Visual Analogue Scale (VAS) Scores | From baseline to Weeks 12 and 24 | Percent Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch. |
| Secondary | Absolute Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores | From baseline to Weeks 12 and 24 | Absolute Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome. |
| Secondary | Percent Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores | From baseline to Weeks 12 and 24 | Percent Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03226067/registered