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

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ClinicalTrials.gov Identifier: NCT05448170
Expanded Access Status : Available
First Posted : July 7, 2022
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment
Pruritus Drug: Linerixibat

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Interventions
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Intervention Details:
  • Drug: Linerixibat
    open label investigational product
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05448170


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05448170    
Other Study ID Numbers: 217327
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: November 2023
Keywords provided by GlaxoSmithKline:
Linerixibat
Individual Patient Compassionate Use
Primary Biliary Cholangitis
Ileal bile acid transporter (IBAT) inhibitor
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Pruritus
Skin Diseases
Skin Manifestations
Bile Duct Diseases
Biliary Tract Diseases
 Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis
Fibrosis
Pathologic Processes