Health TrialsbyHealthPanel

TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

ConditionsPruritusPrimary 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nalmefene

    Drug

    Th-104 Nalmefene Mucoadhesive Buccal strip

  • Placebo

    Drug

    Matching placebo to TH-104

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The primary objective is to investigate the safety and tolerability of repeat doses of TH104

Percentage of participants with treatment-related adverse events as coded by MedDRA.

Time frame
42 days

Secondary outcomes

1

Difference in daily itch score between TH104 and placebo

Time frame
42 days
2

Change in participants reported outcome for PBC-40 questionnaire

The PBC-40 is a disease specific questionnaire that assess PBC related symptoms . The six domains of PBC-40 relate to fatigue, emotional, social, and cognitive function, general symptoms, and itch

Time frame
42 days
3

Change in participants reported outcome for 5-D itch questionnaire.

The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.

Time frame
42 days
4

Change in participants reported outcome for EQ5D quality of life questionnaire

EQ-5D assesses health status in terms of five dimensions of health.

Time frame
42 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tharimmune Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: