Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

  • STATUS
    Recruiting
  • End date
    Nov 23, 2023
  • participants needed
    230
  • sponsor
    GlaxoSmithKline
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Updated on 4 October 2022
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Summary

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

Details
Condition Pruritus
Treatment Placebo, Linerixibat
Clinical Study IdentifierNCT04950127
SponsorGlaxoSmithKline
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent
Participants who have documented PBC
Participants who have moderate to severe itch

Exclusion Criteria

Symptoms suggestive of active coronavirus disease 2019 (COVID-19) infection whilst symptoms persist or known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days from the exposure
Total bilirubin >2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures
Screening Alanine Aminotransferase (ALT) > 6 times ULN in a single Baseline measure or ALT > 5 times ULN using the average of two Baseline measures
Screening estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (mL/min/1.73m^2)
History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites)
Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer
Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment
Current symptomatic cholelithiasis or cholecystitis
Current diagnosis of primary skin disorders with itch symptoms (e.g., atopic dermatitis, psoriasis)
Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia
Current/previous diagnosis of colorectal cancer
Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening
Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study)
Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching
Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening
Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study
History of sensitivity or intolerance to the study treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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