Trial · NCT04167358
Linerixibat Long-term Safety, and Tolerability Study
NCT04167358, Phase 3, Active not recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Linerixibat Long-term Safety, and Tolerability Study. Trials, record NCT04167358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04167358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Linerixibat Long-term Safety, and Tolerability Study
- NCT number
- NCT04167358
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 242 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cholestasis
- Interventions
- Linerixibat
- First posted
- 2019-11-18
- Last updated
- 2026-06-22
- Other registries' IDs
- eudract:2019-003158-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04167358
GET https://conductscience.org/api/trials/v1/NCT04167358/registered