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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: Placebo to match TQA3526; Drug: TQA3526

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278820

TQA3526-Ⅱ-01

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

130 participants in 3 patient groups

Climbing group

Experimental group

Treatment:

Drug: Placebo to match TQA3526

Drug: TQA3526

Titration group

Experimental group

Treatment:

Drug: Placebo to match TQA3526

Drug: TQA3526

Extension group

Experimental group

Treatment:

Drug: Placebo to match TQA3526

Drug: TQA3526