- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278820
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
February 18, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Conditions
Intervention / Treatment
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
- Name: Junqi Niu
- Phone Number: 13756661205
- Email: junqiniu@aliyun.com
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130000
- The First Hospital of Jilin University
-
Contact:
- Junqi Niu
- Phone Number: 13756661205
- Email: junqiniu@aliyun.com
-
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQA3526-Ⅱ-01
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.
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