Trial · NCT04167358
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs) | Up to 66 months | AEs and SAEs will be collected. |
| Primary | Number of participants with Severe AEs | Up to 66 months | AEs and SAEs will be collected. |
| Secondary | Change in domain scores of the PBC-40 over time | Baseline and up to 65 months | The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional). |
| Secondary | Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only) | Baseline and up to 65 months | The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems. |
| Secondary | Change in self-rated health by EQ VAS scores over time (Group 1 only) | Baseline and up to 65 months | The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. |
| Secondary | Change in the Beck Depression Inventory (BDI-II) scores over time | Baseline and up to 65 months | The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression. |
| Secondary | Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters | Baseline and up to 65 months | Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters. |
| Secondary | Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only) | Week 24 and Week 52 of continuous treatment | Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (\>=) 2, \>=3, and \>=4-point reduction in MIS will be assessed. |
| Secondary | Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only) | Week 52 of continuous treatment | The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (\>=2, \>=3, and \>=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment. |
| Secondary | Change from Baseline Monthly Sleep Score (MSS) (Group 2 only) | Baseline and up to Week 52 of continuous treatment | The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment. |
| Secondary | Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only) | Baseline and up to Week 52 of continuous treatment | The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment. |
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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