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
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
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
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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