Un-randomized, Open, Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules (GLS4) /Ritonavir Tablets(RTV) in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The mean value of HBV DNA decreased from baseline
研究概览
简要总结
The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B
详细描述
Un-randomized, open Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B
20 subjects with Chronic Hepatitis B will be enrolled. 10 subjects will be assigned to group A and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg twice daily for 48 weeks. 10 subjects will be assigned to group B and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg three times daily for 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed informed consent form.
- •Positive HBsAg, positive or negative HBeAg, negative immunoglobulin M( if immunoglobulin M is positive, subject should have laboratory report showed that subject had HBsAg or HBV DNA positive more than 6 months) ; Positive HBsAg, positive or negative HBeAg, liver biopsy report showed evidence of chronic HBV infection, in the case of liver biopsy results, the liver biopsy results shall prevail.
- •Subjects who have not received any antiviral treatment; or if Subjects received treatment with interferon/Peg-interferon, or anti-HBV nucleoside drugs, the drugs should be discontinued at least 3 months prior to the screening.
- •For the subject HBeAg is positive, HBV DNA≥1.0×105 IU/mL（PCR）;For the subject HBeAg is negative , HBV DNA≥1.0×104 IU/mL（PCR）
- •1.3×ULN≤serum alanine aminotransferase(ALT) ≤5×ULN；
- •18~65 years old,
排除标准
- •Investigator assessed subjects have other clinically significant abnormalities (other than HBV), such as uncontrollable heart disease, gastrointestinal, blood, nervous or other medical disorders, which may interfere with treatment, assessment, or compliance with the protocol;
- •Laboratory results do not comply with the acceptance criteria at screening;
- •People with positive urinalysis(Such as opioids, barbiturates, benzodiazepines, tricyclic antidepressants, phencyclidine, except for there is document proof that urinalysis positive result due to subject use short period or long period of prescription drug or over-the-counter(OTC) drug.
- •Pregnant female or breast-feeding woman.
- •The result of Fibroscan test was conducted within 6 months before screening is showed that fibroscan score 17.5, or Liver tissue test which was conducted within 24 months before screening showed cirrhosis
研究组 & 干预措施
GLS4 120 mg+ RTV 100mg，bid
Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg twice daily for 48 weeks.
干预措施: RTV (Drug)
GLS4 120 mg+ RTV 100mg，bid
Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg twice daily for 48 weeks.
干预措施: GLS4 (Drug)
GLS4 120 mg+ RTV 100mg，tid
Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg three times daily for 48 weeks .
干预措施: GLS4 (Drug)
GLS4 120 mg+ RTV 100mg，tid
Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg three times daily for 48 weeks .
干预措施: RTV (Drug)
结局指标
主要结局
The mean value of HBV DNA decreased from baseline
时间窗: Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.
The mean value of HBV DNA (unit IU/ml) at different time points in each group was lowered compared with baseline.
Adverse events
时间窗: From the baseline to 7 days after drug withdrawal.
To assess the safety and tolerability after dosing.
次要结局
- The mean value of serum HBsAg decreased from baseline.(Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.)
- The mean value of serum HBeAg(if any) decreased from baseline.(Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.)
- Cmax(Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.)
- AUC(Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.)
- Css_min(Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.)