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Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

Primary Purpose

Pruritus

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Linerixibat
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Pruritus focused on measuring Linerixibat, Individual Patient Compassionate Use, Primary Biliary Cholangitis, Ileal bile acid transporter (IBAT) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Participants with moderate/severe cholestatic pruritus associated to PBC who are unable to participate or do not qualify for enrollment in the ongoing linerixibat phase 3 clinical trials (NCT04167358 and NCT04950127 studies)
  • Male and female ≥ 18 years of age
  • Participants who have failed available treatment alternatives for cholestatic pruritus in PBC
  • Contraceptive/Barrier Requirements (applicable for female participants only):

A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  • Is not a woman of childbearing potential (WOCBP) OR
  • Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat.

Exclusion Criteria:

  • Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy).
  • Use of obeticholic acid or other IBAT inhibitor

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2022
    Last Updated
    July 1, 2022
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05448170
    Brief Title
    Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)
    Official Title
    Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have moderate/severe cholestatic pruritus associated to PBC who have failed available treatment options and are unable or do not qualify to participate in the linerixibat Phase III clinical studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pruritus
    Keywords
    Linerixibat, Individual Patient Compassionate Use, Primary Biliary Cholangitis, Ileal bile acid transporter (IBAT) inhibitor

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Linerixibat
    Intervention Description
    open label investigational product

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Participants with moderate/severe cholestatic pruritus associated to PBC who are unable to participate or do not qualify for enrollment in the ongoing linerixibat phase 3 clinical trials (NCT04167358 and NCT04950127 studies) Male and female ≥ 18 years of age Participants who have failed available treatment alternatives for cholestatic pruritus in PBC Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat. Exclusion Criteria: Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy). Use of obeticholic acid or other IBAT inhibitor
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    US GSK Clinical Trials Call Center
    Phone
    877-379-3718
    Email
    GSKClinicalSupportHD@gsk.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    EU GSK Clinical Trials Call Center
    Phone
    +44 (0) 20 89904466
    Email
    GSKClinicalSupportHD@gsk.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

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