Phase
Condition
Primary Biliary Cholangitis
Treatment
GSK4532990
Placebo
Clinical Study ID
Ages 18-65 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.
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
Adelaide, South Australia 5000
AustraliaSite Not Available
GSK Investigational Site
Murdoch, Western Australia 6150
AustraliaSite Not Available
GSK Investigational Site
Perth, Western Australia 6000
AustraliaSite Not Available
GSK Investigational Site
Melbourne, 3004
AustraliaSite Not Available
GSK Investigational Site
Parkville Melbourne, 3050
AustraliaSite Not Available
GSK Investigational Site
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
GSK Investigational Site
New Westminster, British Columbia V3L 3W4
CanadaSite Not Available
GSK Investigational Site
London, Ontario N6A 5A5
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2C4
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H2X 0A9
CanadaSite Not Available
GSK Investigational Site
Terrebonne, Quebec J6X 4P7
CanadaActive - Recruiting
GSK Investigational Site
Esbjerg,
DenmarkSite Not Available
GSK Investigational Site
Odense C, 5000
DenmarkSite Not Available
GSK Investigational Site
Angers Cedex 9, 49933
FranceSite Not Available
GSK Investigational Site
Bobigny cedex, 93000
FranceSite Not Available
GSK Investigational Site
CrEteil Cedex, 94000
FranceSite Not Available
GSK Investigational Site
Lille, 59037
FranceSite Not Available
GSK Investigational Site
Rouen cedex, 76031
FranceSite Not Available
GSK Investigational Site
Berlin, 10787
GermanySite Not Available
GSK Investigational Site
Kiel, 24105
GermanySite Not Available
GSK Investigational Site
Leipzig, 04103
GermanySite Not Available
GSK Investigational Site
Bergamo, 24127
ItalyActive - Recruiting
GSK Investigational Site
Bologna, 40138
ItalySite Not Available
GSK Investigational Site
Messina, 98124
ItalySite Not Available
GSK Investigational Site
Milano, 20162
ItalyActive - Recruiting
GSK Investigational Site
Padova, 35131
ItalySite Not Available
GSK Investigational Site
Roma, 00128
ItalySite Not Available
GSK Investigational Site
Chiba, 286-8520
JapanActive - Recruiting
GSK Investigational Site
Gunma, 371-8511
JapanSite Not Available
GSK Investigational Site
Kagawa, 760-0017
JapanSite Not Available
GSK Investigational Site
Nara, 634-8522
JapanSite Not Available
GSK Investigational Site
Osaka, 565-0871
JapanSite Not Available
GSK Investigational Site
Saitama, 350-0495
JapanSite Not Available
GSK Investigational Site
Shizuoka, 431-3192
JapanSite Not Available
GSK Investigational Site
Tokyo, 180-8610
JapanSite Not Available
GSK Investigational Site
Ansan, 15355
Korea, Republic ofActive - 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
Acapulgo, 39670
MexicoSite Not Available
GSK Investigational Site
Ciudad de Mexico, 11510
MexicoSite Not Available
GSK Investigational Site
DF, 14080
MexicoSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainActive - Recruiting
GSK Investigational Site
Leon, 24071
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Santander, 39011
SpainActive - Recruiting
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Valencia, 46014
SpainActive - Recruiting
GSK Investigational Site
Valladolid, 47003
SpainSite Not Available
GSK Investigational Site
Stockholm, SE-141 86
SwedenSite Not Available
GSK Investigational Site
Uppsala, 753 09
SwedenSite Not Available
GSK Investigational Site
Istanbul, 34010
TurkeySite Not Available
GSK Investigational Site
Izmir, 35100
TurkeySite Not Available
GSK Investigational Site
Glasgow Strathclyde, G51 4TF
United KingdomActive - Recruiting
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
Liverpool, L9 7AL
United KingdomSite Not Available
GSK Investigational Site
London, W2 1NY
United KingdomActive - Recruiting
GSK Investigational Site
Middlesbrough, TS4 3BW
United KingdomSite Not Available
GSK Investigational Site
Chandler, Arizona 85224
United StatesActive - Recruiting
GSK Investigational Site
Phoenix, Arizona 85006
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 90033
United StatesActive - Recruiting
GSK Investigational Site
Brandon, Florida 33511
United StatesActive - Recruiting
GSK Investigational Site
Miami Lakes, Florida 33016
United StatesActive - Recruiting
GSK Investigational Site
Indianapolis, Indiana 46202
United StatesActive - Recruiting
GSK Investigational Site
Marrero, Louisiana 70072
United StatesActive - Recruiting
GSK Investigational Site
Detroit, Michigan 48202
United StatesActive - Recruiting
GSK Investigational Site
New York, New York 10029
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19014
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75235
United StatesSite Not Available
GSK Investigational Site
McAllen, Texas 78503
United StatesActive - Recruiting
GSK Investigational Site
San Antonio, Texas 78215
United StatesActive - Recruiting
GSK Investigational Site
Richmond, Virginia 23249
United StatesActive - Recruiting
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