J-LINX: Japan LINerixibat eXtension Study
ConditionPruritus
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline
About this trial
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Participants will continue receiving linerixibat while researchers monitor adverse events and other safety measures to better understand the long-term safety of treatment and provide continued access to therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into an eligible linerixibat clinical study prior to LLSAT (GLIMMER or GLISTEN)
Participants must have completed the main treatment period in LLSAT
Is a woman of non-childbearing potential (WONCBP), OR
Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum until 4 weeks after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention, etc.)
Disqualifiers
Participants who met LLSAT protocol-defined Liver Monitoring or Liver Stopping criteria and who remain off study treatment or where Liver Event is not resolved at the Final Visit in LLSAT
Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites)
Presence of confirmed hepatocellular carcinoma or biliary cancer
Current clinically significant diarrhea in the investigator's medical opinion
Trial design
Design model
Single group
Treatments tested in this trial
Linerixibat
DrugLinerixibat will be administered.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: LinerixibatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame
Up to approximately 18 months (End of study)2
Number of Participants With AEs by Severity
Time frame
Up to approximately 18 months (End of study)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: