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

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04278820
• Other study ID #: TQA3526-?-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 20, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Junqi Niu
• Phone: 13756661205
• Email: junqiniu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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; ? Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (anti-GP210 and anti-SP100 positive); ? 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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• TQA3526
Tablet(s) administered orally once daily
• Placebo to match TQA3526
Tablet(s) administered orally once daily

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alkaline phosphatase (ALP)	The reduction of ALP level from baseline to 24 weeks.	Baseline up to 24w
Secondary	Liver function:ALP (excluding 12W/24W), ALT, AST, GGT, TBA and Tbil	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
Secondary	Fasting lipid:LDL-C?HDL-C?TG and TC	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
Secondary	Cmax	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
Secondary	tmax	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
Secondary	AUC0-8	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
Secondary	pharmacodynamics	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
Secondary	safety and tolerability: incidence of treatment emergent adverse events and serious treatment emergent adverse events	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