NCT04278820Unknown2 期
A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of TQA3526 in the Treatment of Naive or Previously Treated PBC Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Alkaline phosphatase (ALP)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Extension group
Experimental
干预措施: Placebo to match TQA3526 (Drug)
Climbing group
Experimental
干预措施: TQA3526 (Drug)
Climbing group
Experimental
干预措施: Placebo to match TQA3526 (Drug)
Titration group
Experimental
干预措施: TQA3526 (Drug)
Titration group
Experimental
干预措施: Placebo to match TQA3526 (Drug)
Extension group
Experimental
干预措施: TQA3526 (Drug)
结局指标
主要结局
Alkaline phosphatase (ALP)
时间窗: Baseline up to 24w
The reduction of ALP level from baseline to 24 weeks.
次要结局
- Liver function：ALP (excluding 12W/24W), ALT, AST, GGT, TBA and Tbil(Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks)
- Fasting lipid：LDL-C、HDL-C、TG and TC(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(Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks)
- AUC0-∞(predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration)
- pharmacodynamics(Baseline up to 2, 4, 8, 12, 14, 16, 20, 24 weeks)
- tmax(predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration)
- Cmax(predose, Weeks 2, 4, 8, 12, 14, 16, 20, 24 : 0, 1.5, 3.5 hours following drug administration)
研究者
研究点 (1)
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