Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 147 people in total across six groups. Participants had primary biliary cholangitis (PBC), a liver condition, and were experiencing itching. The trial was measuring whether different doses of a medicine called GSK2330672 — taken either once or twice a day — changed the severity of itching compared to a dummy treatment (placebo) over roughly 16 weeks. The study also looked at certain liver-related markers in the blood, and at participants' quality of life using a standardised questionnaire. The reported data shows that, for the main outcome — change in worst daily itch score on a 0–10 scale — all groups reported a reduction in their itch score from their starting point. The placebo group reported an average reduction of 1.73 points. The five GSK2330672 dose groups reported average reductions ranging from 2.19 points (20 mg once daily) to 2.86 points (40 mg twice daily). For the quality-of-life questionnaire focused on itch (scored 3–15, where higher means worse), the placebo group reported a change of −2.3 points, while GSK2330672 groups reported changes ranging from −1.9 to −3.4 points. For blood markers related to liver health (ALP, ALT, and AST), the reported changes varied across the dose groups, with some groups showing decreases and others showing increases from their starting values; the reported data does not allow a straightforward pattern to be drawn across all doses. Only one participant (in the 90 mg twice-daily group) met the specific threshold for a favourable liver marker response at Week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38780109) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Primary Biliary Cholangitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 80 years old at the time of signing the consent form.
- People who have a confirmed diagnosis of Primary Biliary Cholangitis (PBC), shown by at least 2 of the following: a history of certain abnormal liver blood test results (raised ALP levels) first noticed at least 6 months before the screening visit; a positive blood test for specific antibodies linked to PBC; or a past liver biopsy that is consistent with PBC.
- People who have rated their itching as 4 or higher (on a scale of 0 to 10) on most days during the 8 weeks before the screening visit, even if some days had little or no itch, as long as the worst daily itch score reached 4 or higher on most days.
- People currently taking a medication called UDCA (ursodeoxycholic acid) who have been on a stable dose for more than 8 weeks before screening, or people who stopped taking UDCA due to side effects at least 8 weeks before screening.
- Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use reliable contraception during the treatment period and for at least 4 weeks after the last dose of the study treatment.
- People who are able to understand and agree to the trial requirements and sign a consent form.
Who may not be able to join:
- People whose screening blood tests show certain liver markers (total bilirubin) more than twice the upper limit of normal, unless specific further testing shows the direct bilirubin portion is below 35%.
- People whose screening blood tests show certain liver enzymes (ALT or AST) more than 6 times the upper limit of normal.
- People whose kidneys are not functioning well enough, based on a specific kidney function calculation at screening (confirm with trial site).
- People who have had or currently have serious liver complications such as bleeding from abnormal blood vessels, confusion caused by liver failure, or fluid build-up in the abdomen.
- People with an active hepatitis B or C virus infection, or confirmed liver or bile duct cancer.
- People who currently have diarrhoea.
- People who currently have painful gallstones or an inflamed gallbladder, unless their gallbladder was surgically removed at least 3 months before screening.
- People with a current medical condition — such as a psychiatric disorder, severe memory loss, or dementia — that may make it difficult to follow the trial requirements.
- People who started or increased the dose of colchicine, methotrexate, azathioprine, or steroid tablets within the 2 months before screening, or where a dose change is planned during the study.
- People who started or increased the dose of bezafibrate or fenofibrate within the 3 months before screening (stable doses may be acceptable, but no changes are allowed during the main study period).
- People who started or increased the dose of rifampicin, naltrexone, naloxone, nalfurafine, or sertraline within the 8 weeks before screening (stable or reduced doses may be acceptable, but no changes are allowed during the main study period).
- People currently using certain cholesterol-lowering resins (cholestyramine, colesevelam, colestipol, or colestimide), as these must be stopped before the study begins.
- People who have used a medication called obeticholic acid unless it has been stopped for at least 8 weeks before the study begins.
- People who have used any other medication that blocks a specific gut protein called IBAT (Ileal Bile Acid Transporter) within the 3 months before screening.
- People who are currently in, or have participated in, another clinical trial involving an experimental treatment within the 8 weeks before the start of this study.
- People whose heart electrical activity test (ECG) shows a specific measurement called the QTc interval above 480 milliseconds.
- People with a known allergy or sensitivity to the study drug or its ingredients, or any drug allergy that the study doctor considers a reason not to participate.
- People who have regularly consumed more than 21 units of alcohol per week (for men) or more than 14 units per week (for women) in the 6 months before the study, where one unit equals roughly half a pint of beer, a small glass of wine, or a single measure of spirits.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: GSK Clinical Trials, GlaxoSmithKline
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.