← Back to Search

Bile Acid Sequestrant

Linerixibat for Cholestasis (LLSAT Trial)

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 66 months
Awards & highlights

LLSAT Trial 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.

Who is the study for?
This trial is for adults aged 18-80 with primary biliary cholangitis (PBC) and itching, who've been in a prior linerixibat study. They must not be pregnant or breastfeeding, have significant liver function issues, certain cancers, severe kidney problems, or use conflicting medications.Check my eligibility
What is being tested?
The trial tests the long-term safety of linerixibat in patients with PBC-related itching. It's an open-label study where all participants receive the drug. The duration varies until linerixibat becomes legally available to them.See study design
What are the potential side effects?
Potential side effects of linerixibat may include gastrointestinal symptoms like diarrhea. Since it's focused on long-term safety, monitoring will capture any new or ongoing side effects.

LLSAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old and have consented to participate in a trial.
Select...
I have PBC and itching, and was in a linerixibat trial (BAT117213, GLIMMER, GLISTEN).
Select...
I am able to understand and sign the consent form.
Select...
I am not pregnant or breastfeeding, and either cannot have children or am using birth control.

LLSAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 66 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 66 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Severe AEs
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
Secondary outcome measures
Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)
Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)
Change in domain scores of the PBC-40 over time
+6 more

LLSAT Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving linerixibatExperimental Treatment1 Intervention
Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linerixibat
2022
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,748 Previous Clinical Trials
8,067,207 Total Patients Enrolled
5 Trials studying Cholestasis
210 Patients Enrolled for Cholestasis
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,673 Total Patients Enrolled
5 Trials studying Cholestasis
210 Patients Enrolled for Cholestasis

Media Library

Linerixibat (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT04167358 — Phase 3
Cholestasis Research Study Groups: Participants receiving linerixibat
Cholestasis Clinical Trial 2023: Linerixibat Highlights & Side Effects. Trial Name: NCT04167358 — Phase 3
Linerixibat (Bile Acid Sequestrant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167358 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~133 spots leftby Feb 2027