Trial · NCT04526665
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52 | At Week 52 | The ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Key Secondary Endpoint: Percentage of Participants With Response to Treatment Based on ALP Normalization at Week 52 | At Week 52 | The ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch Numeric Rating Scale (NRS) Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 52 | Baseline (up to 14 days pre-dose) and Week 52 | The Pruritus ITT population included all participants from the ITT analysis set with baseline PBC Worst Itch NRS score ≥4. Only those participants with data collected at Week 52 are reported. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch NRS Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 24 | Baseline (up to 14 days pre-dose) and Week 24 | The Pruritus ITT population included all participants from the ITT analysis set with baseline PBC Worst Itch NRS score ≥4. Only those participants with data collected at Week 24 are reported. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ALP at Weeks 4, 13, 26, 39 and 52 | Baseline (Day 1) and at Weeks 4, 13, 26, 39 and 52 | The ITT population included all randomized participants. Only those participants with data collected at specified timepoints are reported. | Units per Liter (U/L) | MEAN |
| SECONDARY | Percentage of Participants With ALP Response From Baseline at Week 52 | Baseline (Day 1) and at Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to ALP < 1.5x ULN, ALP Decrease From Baseline >= 40% and TB =<ULN at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to ALP < 3x ULN, Aspartate Aminotransferase (AST) < 2x ULN and TB =< 1 Milligrams Per Deciliter (mg/dL) (Paris I) at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to ALP =< 1.5x ULN, AST =< 1.5x ULN and TB =< 1 mg/dL (Paris II) at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to TB Decrease of 15% Change From Baseline at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to Normalization of TB (TB =< ULN) and/or Albumin (ALB >= Lower Limit of Normal [LLN]) (Rotterdam) at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to TB ≤0.6 x ULN at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to ALP ≤1.67 x ULN and TB ≤1 mg/dL (Momah/ Lindor) at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to no Worsening of TB at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment According to Complete Biochemical Response at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Percentage of participants | NUMBER |
| SECONDARY | PBC 5-, 10- and 15-year Risk Scores Based on United Kingdom (UK)-PBC Score at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Scores on a scale | MEAN |
| SECONDARY | Global PBC Study Group (GLOBE) Score at Week 52 | At Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Hepatobiliary Injury and Liver Function as Assessed by AST, ALT, Gamma-glutamyl Transferase (GGT), 5 Prime Nucleotidase (5'-NT), and Fractionated ALP (Hepatic) (H1 and H2) at Week 52 | Baseline (Day 1) and at Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 for each parameter are reported. | U/L | MEAN |
| SECONDARY | Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Total and Conjugated Bilirubin at Week 52 | Baseline (Day 1) and at Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 for each parameter are reported. | Micromoles per liter (μmol/L) | MEAN |
| SECONDARY | Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Albumin at Week 52 | Baseline (Day 1) and at Week 52 | The ITT population included all randomized participants. Only those participants with data collected at Week 52 are reported. | Grams per liter (g/L) | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04526665/outcomes