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 tested an investigational medicine called HTD1801 in people with a liver condition. Participants were split into three groups: one taking a lower dose of HTD1801 (500 mg twice daily), one taking a higher dose (1,000 mg twice daily), and one taking a placebo (a dummy treatment with no active ingredient). The trial ran in three back-to-back periods. In the first period, 16, 25, and 18 people started in each group respectively. The trial was primarily measuring changes in a liver enzyme in the blood called alkaline phosphatase (ALP) — a substance doctors sometimes monitor as a marker of liver stress — over the first six weeks. The reported data shows that after six weeks (Period 1), average ALP levels fell by 71 units per litre (U/L) in the lower-dose group and by 73 U/L in the higher-dose group, while the placebo group's average ALP level rose by 94 U/L. For the secondary measures during this same six-week period: the number of participants whose ALP dropped to below 1.5 times the upper limit of the normal range was 2 (lower dose), 6 (higher dose), and 1 (placebo). The number who achieved a 50% drop in ALP was 1, 4, and 0 respectively, and the number whose ALP returned fully to the normal range was 0, 2, and 0. Average total bilirubin (another liver-related blood marker) changed by −0.2, 0.0, and +0.1 mg/dL across the three groups. In the second six-week period, participants who had been on placebo and switched to the higher dose showed an average ALP drop of 189 U/L, while other subgroups showed smaller or no notable changes. 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 36327436) ↗
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:
- You are between 18 and 75 years old (male or female)
- You have been diagnosed with Primary Sclerosing Cholangitis (PSC), a liver condition involving blocked or scarred bile ducts, confirmed by a specific scan (MRCP or ERCP) and present for more than 6 months
- Your blood test shows a liver enzyme called ALP is at least 1.5 times higher than the normal range
- If you have Inflammatory Bowel Disease (IBD), it has been confirmed for at least 6 months and your IBD symptoms are mild or well-controlled (confirm with trial site)
- If you take certain medications for IBD (such as mesalazine, azathioprine, 6-mercaptopurine, methotrexate, or biologic drugs), you have been on a stable dose for at least 3 months
- You are able to read and sign a consent form showing you understand the trial
- Any other permitted medications you take have been at a stable dose for at least 28 days before the study starts (or at least 6 weeks for a medication called ursodeoxycholic acid/UDCA)
Who may not be able to join:
- You have been diagnosed with a different type of bile duct scarring caused by another condition (such as pancreatitis, gallstones, infection, injury, or chemical damage)
- You have a less common form called "small duct PSC" (confirm with trial site)
- You currently have a drain or stent placed in your bile duct
- You have a history of bile duct cancer (cholangiocarcinoma), or a new suspicious narrowing in your bile duct has been found within the last year
- You have had a serious bile duct infection called ascending cholangitis within the last 60 days
- You have a history of alcohol or drug misuse or dependency
- You have had, or are planning to have, a liver transplant
- You have another liver condition such as alcoholic liver disease, fatty liver disease (NASH), primary biliary cirrhosis, or autoimmune hepatitis
- Your blood test results show signs of advanced liver problems, including low platelet count, low albumin, or an abnormal clotting measure (INR above 1.2), or you have a history of fluid build-up in the abdomen, confusion caused by liver disease, or bleeding from veins in the food pipe
- Your IBD has been severely active or significantly worsened in the last 90 days and required stronger treatment
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1
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.