CompletedPhase 2

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

United States24 participantsStarted 2021-05-27

Plain-language summary

The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Biochemical evidence of cholestasis with elevation of ALP activity
✓. Presence of antimitochondrial antibody (AMA)
✓. Histopathologic evidence of non-suppurative cholangitis and destruction of small or medium-sized bile ducts if biopsy performed Note: historical AMA and liver biopsy data may be used but must be recorded in source documentation.

What they're measuring

Percent Change in Alkaline Phosphatase (ALP) at Week 12 Compared to Baseline

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT04604652

SponsorHighTide Biopharma Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-31

Results submitted2023-09-07

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials