Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503465-33-00

Acronym

212358

Enrollment

Registered

2023-08-24

Start date

2020-07-03

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis

Brief summary

"Frequency and severity of adverse events - From start of treatment (Day1) to end of study or until the follow up phone call after early study withdrawal (Day 7 to 14 post-final dose of IP). Assessments are made on Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 (Additional visits as needed) and final follow phone call on Day 7 to Day 14 post final dose of IP. "

Detailed description

"1. Change in domain scores of the PBC-40 and BDI-II over time 2. Change in clinically meaningful lab values incl. liver parameters and lipids over time Group 1 only 2. Change in health-related QoL and EQ VAS (EQ-5D-3L) over time. Group 2 only (Responder=R = ≥2, ≥3 and ≥4 points reduction in MIS) 1. R at w24, at w52 of continuous treatment 2. Maintenance of efficacy at w52 for those who were R at w24 3. Change from Baseline in Monthly Sleep and Fatigue Scores over 52 w of cont. treatment"

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
"Frequency and severity of adverse events - From start of treatment (Day1) to end of study or until the follow up phone call after early study withdrawal (Day 7 to 14 post-final dose of IP). Assessments are made on Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 (Additional visits as needed) and final follow phone call on Day 7 to Day 14 post final dose of IP. "	—

Secondary

Measure	Time frame
"1. Change in domain scores of the PBC-40 and BDI-II over time 2. Change in clinically meaningful lab values incl. liver parameters and lipids over time Group 1 only 2. Change in health-related QoL and EQ VAS (EQ-5D-3L) over time. Group 2 only (Responder=R = ≥2, ≥3 and ≥4 points reduction in MIS) 1. R at w24, at w52 of continuous treatment 2. Maintenance of efficacy at w52 for those who were R at w24 3. Change from Baseline in Monthly Sleep and Fatigue Scores over 52 w of cont. treatment"	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Greece, Italy, Poland, Spain

Outcome results