Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 21.1 Level: PT Classification code 10064190 Term: Cholestatic pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0 Level: PT Classification code 10080429 Term: Primary biliary cholangitis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply: Age 1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant’s parent trial BAT117213 or 201000 Type of Participant and Disease Characteristics 2. Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial(BAT117213 or 201000) 3. Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213 or 201000) Sex 4. Male or female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraception by male participants or male partners of female participants is not required in this protocol a. Female Participants: -A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: o Is not a woman of childbearing potential (WOCBP) OR o Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Screening total bilirubin >2x ULN. Total bilirubin >2x ULN is acceptable if bilirubin is fractionated and direct bilirubin 6x ULN 3. Screening estimated glomerular filtration rate (eGFR) 480 msec NOTES: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Frederica’s formula (QTcF), and/or another method. It is either machine-read or manually over-read The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study and maintained for individual participants throughout study participation. The specific QT correction formula used must be specified in the eCRF A QTc >480 msec (12-lead ECG) at screening is exclusionary Note: The QT interval will be assessed at screening and at each long visit (yearly) by 12-Lead ECG. QTc stopping criteria are established for this study and are detailed in [Section 7.1.2] of Protocol Other Exclusions 14. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of long-term linerixibat treatment in participants with cholestatic pruritus in PBC;Secondary Objective: -To characterize the effects of long-term linerixibat treatment on disease burden and health related QOL in participants with cholestatic pruritus in PBC -To characterize the effects of long-term linerixibat treatment in PBC population ;Primary end point(s): Frequency and severity of adverse events;Timepoint(s) of evaluation of this end point: From start of treatment (Day1) to follow up phone call (Day 7 to 14 post-final dose of IP). Assessments are made on Day 1, Week 1, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48 and final follow phone call on Day 7 to Day 14 post final dose of IP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change in domain scores of the PBC-40 over time 2.Change in health-related QoL by the EQ-5D-3L summary index number (utility) over time 3.Change in the EQ VAS (within the EQ-5D-3L) over time 4.Change in the BDI-II over time 5.Trends in clinically meaningful laboratory values including liver parameters and lipids over time;Timepoint(s) of evaluation of this end point: For secondary endpoints numbers 1-4 the timepoints of evaluation are: From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24,Month 30, Month 36, Month 42 and Month 48. For secondary endpoint number 5 the timepoints of evaluation are: From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 24, Month 36 and Month 48. | — |
Countries
Belgium, Bulgaria, Canada, France, Greece, Italy, Japan, Poland, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed