TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTharimmune Inc
About this trial
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
Eligibility criteria
Qualifiers
Men or women aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
history of sustained increased alkaline phosphatase (ALP) levels first recognized at least 6 months prior to the Screening Visit
positive antimitochondrial antibodies (AMA) titer (>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay [ELISA])
PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
Disqualifiers
Screening total bilirubin >2.0 x ULN.
Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >4 x ULN.
Screening serum creatinine >2.5 mg/dL (221 µmol/L).
History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
Trial design
Treatments tested in this trial
- Nalmefene
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov