Primary Biliary CirrhosisPhase 2NCT04278820
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
A Phase 2 study testing TQA3526 in people with Primary Biliary Cirrhosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- TQA3526
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The first hospital of Jilin University
Changchun, Jilin, 130000
Junqi Niu, 13756661205, junqiniu@aliyun.com
Junqi Niu
About this study
Official title: 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).
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- TQA3526, Placebo to match TQA3526
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQA3526Drug
Tablet(s) administered orally once daily
Placebo to match TQA3526Drug
Tablet(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Climbing group | Experimental | Not described Receives: Drug: TQA3526; Drug: Placebo to match TQA3526 |
| Titration group | Experimental | Not described Receives: Drug: TQA3526; Drug: Placebo to match TQA3526 |
| Extension group | Experimental | Not described Receives: Drug: TQA3526; Drug: Placebo to match TQA3526 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alkaline phosphatase (ALP)
The reduction of ALP level from baseline to 24 weeks.
Measured: Baseline up to 24w
Secondary outcomes (7)
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.
Measured: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
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.
Measured: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
Cmax
Maximum concentration of the analyte in plasma.
Measured: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
tmax
Time from dosing to maximum concentration
Measured: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
AUC0-∞
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration
pharmacodynamics
The rate of change of FGF-19、C4、IgG and IgM from baseline to each time point.
Measured: 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
Evaluate safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events comparing TQA3526 to placebo.
Measured: Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Mar 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278820
- Sponsor's protocol ID
- TQA3526-Ⅱ-01
- Status last verified
- Dec 2019
- First submitted
- 18 Jan 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of TQA3526 in the Treatment of Naive or Previously Treated PBC Patients
- ClinicalTrials.gov ID
- NCT04278820
- Acronym / sponsor ID
- TQA3526-Ⅱ-01
- Conditions
- Primary Biliary Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Climbing group | Experimental | Drug: TQA3526, Drug: Placebo to match TQA3526 |
| Titration group | Experimental | Drug: TQA3526, Drug: Placebo to match TQA3526 |
| Extension group | Experimental | Drug: TQA3526, Drug: Placebo to match TQA3526 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQA3526Tablet(s) administered orally once daily | Drug | Climbing group, Extension group, Titration group |
| Placebo to match TQA3526Tablet(s) administered orally once daily | Drug | Climbing group, Extension group, Titration group |
Primary outcome
Alkaline phosphatase (ALP)
Time frame: Baseline up to 24w
The reduction of ALP level from baseline to 24 weeks.
7 secondary outcomes
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
Fasting lipid：LDL-C、HDL-C、TG and TC
Time frame: 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
tmax
Time frame: 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
pharmacodynamics
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQA3526 in people with Primary Biliary Cirrhosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junqi Niu (13756661205, junqiniu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alkaline phosphatase (ALP) (time frame: Baseline up to 24w). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.