A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of TQA3526 in the Treatment of Naive or Previously Treated PBC Patients

TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. It is hypothesized that regular treatment with TQA3526 will improve liver function in persons with Primary Biliary Cirrhosis (PBC).

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jilin
      • Changchun, Jilin, China, 130000
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.18 and 70 years old, male or female. 2.Proven as PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:

    • History of increased ALP levels for at least 3 months prior to Day 0 in previously treated PBC patients,or ALP levels increased during screening in treatment naive PBC patients; ② Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (anti-GP210 and anti-SP100 positive); ③ Liver biopsy consistent with PBC within 24W prior to randomization; 3.ALP value between 1.67 and 10 × ULN; 4.Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion Criteria:

  • 1.Has other virus infected ; 2.History or presence of other concomitant liver diseases; 3.Presence of clinical complications of PBC or clinically significant hepatic decompensation; 4.Child-pugh grade B or C in patients with cirrhosis; 5.Creatinine (Cr) ≥1.5 times the upper limit of normal value and serum creatinine clearance rate <60mL/min; 6.ALT or AST>5×ULN;TBil>3×ULN; 7.Patients with a history of severe pruritus within 2 months prior to day 0; 8.History or presence of clinically concerning cardiac arrhythmias, the duration of the study may affect survival; 9.Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine; 10.Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to < 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Climbing group
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Experimental: Titration group
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Experimental: Extension group
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alkaline phosphatase (ALP)
Time Frame: Baseline up to 24w
The reduction of ALP level from baseline to 24 weeks.
Baseline up to 24w

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function:ALP (excluding 12W/24W), ALT, AST, GGT, TBA and Tbil
Time Frame: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
The reduction of ALP , ALT, AST, GGT, TBA and Tbil from baseline to each time point.
Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
Fasting lipid:LDL-C、HDL-C、TG and TC
Time Frame: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
The rate of change of LDL-C、HDL-C、TG and TC from baseline to each time point.
Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
Cmax
Time Frame: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
Maximum concentration of the analyte in plasma.
predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
tmax
Time Frame: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
Time from dosing to maximum concentration
predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
AUC0-∞
Time Frame: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
pharmacodynamics
Time Frame: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
The rate of change of FGF-19、C4、IgG and IgM from baseline to each time point.
Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
safety and tolerability: incidence of treatment emergent adverse events and serious treatment emergent adverse events
Time Frame: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
Evaluate safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events comparing TQA3526 to placebo.
Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2020

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Biliary Cirrhosis

3
Subscribe