Phase
Condition
Primary Biliary Cholangitis
Treatment
Placebo
GSK4532990
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Capable of giving signed informed consent prior to the performance of anystudy-specific procedures.
Able and willing to comply with all study assessments and adhere to the protocolschedule of activities.
In the opinion of the investigator, there is a history of alcohol consumptioncompatible with either ALD or Met ALD.
A female participant is eligible to participate after meeting additional pre-definedcriteria.
Participants must meet predefined stable use requirements of concomitant medicationsbased on study criteria.
Participant has advanced chronic liver disease
Exclusion
Exclusion Criteria:
Meeting any definition of organ system failure as defined by the North AmericanConsortium for Study of End-stage Liver Disease (NACSELD)
Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT),Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets,International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c).Other primary causes of liver disease based on study criteria.
Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) atscreening. Participants under evaluation for possible malignancy at screening arenot eligible.
Prior organ transplant or current listing or active consideration for organtransplant during the screening period (except for corneal transplants).
Chronic or acute, including partial, known portal vein thrombosis.
Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
Any acute cardiovascular event including myocardial infarction, unstable angina,symptomatic heart failure, or cerebrovascular accident in the 6 months prior toscreening.
Poorly controlled hypertension
Clinical suspicion of rhabdomyolysis during the screening period
Clinical suspicion of a bleeding episode during the screening period related toportal hypertension and/or low blood fibrinogen level.
Body Mass Index (BMI) >35 kg/m2 at screening
Any liver-related clinical event that started (onset) <8 weeks prior to Baseline (D1).
Study Design
Connect with a study center
GSK Investigational Site
Buenos Aires,
ArgentinaActive - Recruiting
GSK Investigational Site
Buenos Aires 3435910, 1425
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, 1118
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, 1426
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario, S2002
ArgentinaActive - Recruiting
GSK Investigational Site
Parkville Melbourne, Victoria 2145234 3050
AustraliaActive - Recruiting
GSK Investigational Site
London, Ontario N6A 5A5
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
GSK Investigational Site
Toronto 6167865, Ontario 6093943 M5G 2C4
CanadaActive - Recruiting
GSK Investigational Site
Terrebonne, J6X 4P7
CanadaSite Not Available
GSK Investigational Site
Berlin, 13353
GermanyActive - Recruiting
GSK Investigational Site
Berlin 2950159, 10787
GermanyActive - Recruiting
GSK Investigational Site
Athens, 11527
GreeceActive - Recruiting
GSK Investigational Site
Milan, 20162
ItalyActive - Recruiting
GSK Investigational Site
Milan 6951411, 20162
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20122
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00168
ItalyActive - Recruiting
GSK Investigational Site
Roma 8957247, 00168
ItalyActive - Recruiting
GSK Investigational Site
Kagawa, 760-0017
JapanSite Not Available
GSK Investigational Site
Kagawa 1860837, 761-0793
JapanActive - Recruiting
GSK Investigational Site
Osaka, 564-0013
JapanActive - Recruiting
GSK Investigational Site
Osaka 1853909, 564-0013
JapanActive - Recruiting
GSK Investigational Site
Seoul, 07061
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 138-736
South KoreaActive - Recruiting
GSK Investigational Site
Seoul 1835848, 07061
South KoreaActive - Recruiting
GSK Investigational Site
Barcelona, 08003
SpainActive - Recruiting
GSK Investigational Site
Barcelona 3128760, 08003
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28006
SpainActive - Recruiting
GSK Investigational Site
Madrid 3117735, 28006
SpainActive - Recruiting
GSK Investigational Site
London, W2 1NY
United KingdomActive - Recruiting
GSK Investigational Site
London 2643743, W2 1NY
United KingdomActive - Recruiting
GSK Investigational Site
Tucson, Arizona 85715
United StatesActive - Recruiting
GSK Investigational Site
Los Angeles, California 90033
United StatesActive - Recruiting
GSK Investigational Site
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75203
United StatesActive - Recruiting
GSK Investigational Site
Dallas 4684888, Texas 4736286 75203
United StatesActive - Recruiting
GSK Investigational Site
Richmond, Virginia 23249
United StatesActive - Recruiting
GSK Investigational Site
Richmond 4781708, Virginia 6254928 23249
United StatesActive - Recruiting

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