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

NCT ID: NCT04278820

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-11-30

Brief Summary

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).

Conditions

Primary Biliary Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Climbing group

Group Type: EXPERIMENTAL

TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Placebo to match TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Titration group

Group Type: EXPERIMENTAL

TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Placebo to match TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Extension group

Group Type: EXPERIMENTAL

TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Placebo to match TQA3526

Intervention Type: DRUG

Tablet(s) administered orally once daily

Interventions

TQA3526

Tablet(s) administered orally once daily

Intervention Type: DRUG

Placebo to match TQA3526

Tablet(s) administered orally once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

Junqi Niu

Role: CONTACT

junqiniu@aliyun.com

13756661205

Facility Contacts

Junqi Niu

Role: primary

junqiniu@aliyun.com

13756661205

Other Identifiers

TQA3526-Ⅱ-01

Identifier Type: -

Identifier Source: org_study_id