Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HTD1801 · 3 trials · 13 indications
To evaluate the effects of HTD1801 on serum ALP in adult subjects with PBC who have experienced an inadequate response to standard therapy. Inadequate response is defined as ALP ≥1.5 × upper limit of normal (ULN) despite having been on adequate doses of ursodeoxycholic acid (UDCA) for at least 6 months. A reduction in ALP represents an improvement.
The primary endpoint was the absolute change in liver fat content (LFC) as measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) from Baseline to Week 18.
| Arm | Type | Description |
|---|---|---|
| Open-label | EXPERIMENTAL | HTD1801 (BUDCA) 250 mg tablets. Dosed at 1000 mg BID with food. |
| 500mg HTD1801, bid | EXPERIMENTAL | - |
| 1000mg HTD1801, bid | EXPERIMENTAL | - |
| placebo, bid | PLACEBO_COMPARATOR | - |
| HTD1801 500 mg BID | ACTIVE_COMPARATOR | - |
| HTD1801 1000 mg BID | ACTIVE_COMPARATOR | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| HTD1801 (BUDCA) | DRUG | HTD1801 (BUDCA) 250 mg tablets. Dose 1000 mg twice daily with food for 12 weeks. |
| HTD1801 | DRUG | HTD1801 tablets, 250mg |
| Placebo | DRUG | tablets manufactured to mimic HTD1801 tablets |
Inclusion Criteria: * Have a clinical diagnosis of PBC as confirmed by patient history consistent with the American Association for the Study of Liver Diseases (AASLD) Practice Guideline confirmed by two of the following three criteria: 1. Biochemical evidence of cholestasis with elevation of AL...