Study Summary
This trial is testing the safety and tolerability of the drug linerixibat in people with a condition called cholestatic pruritus, who have participated in other clinical trials for the same drug. All participants will receive linerixibat during the study, which is expected to last until the drug can be made available for general use. The total duration of the study will vary depending on when each participant joins and the availability of the drug in their country.
- Cholestasis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: Up to 66 months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Participants receiving linerixibat
1 of 1
Experimental Treatment
305 Total Participants · 1 Treatment Group
Primary Treatment: Linerixibat · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What is the main focus of this clinical trial?
"The purpose of this trial is to evaluate the number of participants with severe adverse events (AEs) over a period of up to 66 months. Secondary outcomes include change from baseline monthly sleep score (in group 2 only), change in domain scores of the PBC-40 over time, and self-rated health by EQ VAS scores over time (in group 1 only)." - Anonymous Online Contributor
Is this investigation only happening in one state or are there multiple sites?
"The current study is being conducted at 5 sites, which are situated in Seattle, Sacramento, and Dallas. There may be other locations too. If you enroll in the study, it would be ideal to choose a location near to reduce travel costs and time." - Anonymous Online Contributor
How many test subjects are currently involved in this experimental treatment program?
"That is correct. The clinical trial listed on clinicaltrials.gov is recruiting patients. This particular study was posted on July 14th, 2020 with the most recent update happening on November 4th, 2020. They are looking for 305 people to participate across 5 locations." - Anonymous Online Contributor
Are patients who are over 30 years old eligible for this clinical trial?
"The age requirement to participate in this clinical trial is between 18-80 years old." - Anonymous Online Contributor
Eligibility requirements for this clinical test?
"This study is looking for 305 participants of both genders, aged 18-80, who currently suffer from cholestasis. In addition to general age and diagnosis criteria, eligible patients must also have completed the main treatment period in a prior linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN), as well as being able to provide informed consent. For women of childbearing potential, they must be using an acceptable birth control method in addition to meeting all other requirements." - Anonymous Online Contributor
Are there any current openings for patients who wish to enroll in this clinical trial?
"Yes, the trial is still open for recruitment and this is reflected in the most recent update to the listing on clinicaltrials.gov. The study was first posted on July 14th, 2020 and was last updated on November 4th, 2022. They are looking for 305 participants across 5 sites." - Anonymous Online Contributor
What are the known side effects of Linerixibat?
"Linerixibat has received a Phase 3 designation, meaning that there is evidence of efficacy as well as multiple rounds data affirming its safety. Consequently, our team rates it at a 3 on our 1-to-3 scale." - Anonymous Online Contributor