The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI
- Conditions
- Drug-Induced Acute Liver Injury
- Interventions
- Registration Number
- NCT02944552
- Lead Sponsor
- Drug Induced Liver Disease Study Group
- Brief Summary
The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
- Detailed Description
Explore the safety and efficacy of different doses of bicyclol in treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.
The study adopted the design of multi center, randomized, double-blind, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low dose group bicyclol tablet 25mg Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks. high dose group bicyclol tablet 50mg Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks. positive drug control group polyene phosphatidylcholine capsule 456mg Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.
- Primary Outcome Measures
Name Time Method The decline range of serum ALT after 4 weeks of treatment after 4 weeks of treatment The decrease value of serum ALT after 4 weeks of treatment compared to the baseline
- Secondary Outcome Measures
Name Time Method The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks The decrease value of serum AST compared to the baseline
The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks The decrease value of serum ALT compared to the baseline
The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks The decrease rate of serum ALT compared to the baseline
The time from treatment to ALT normalization treatment period The time from treatment to ALT normalization
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks The ratio of subjects whose ALT and AST declined more than 50% compared to the base line
The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks The serum ALT and AST normalization rate
The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks The area under curve of ALT and AST
Trial Locations
- Locations (17)
Beijing Chest Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Ditan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Shanghai Putuo District Central Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Lung Hospital
🇨🇳Shanghai, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The second affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Fuzhou General Hospital of Nanjing Military Command
🇨🇳Fuzhou, Fujian, China
The First affiliated Hospital of Xinxiang Medical University
🇨🇳Weihui, Henan, China
Henan Infectious Diseases Hospital
🇨🇳Zhengzhou, Henan, China
Renji Hospital ，Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
No.85 hospital of PLA
🇨🇳Shanghai, Shanghai, China
Tianjin Haihe Hospital
🇨🇳Tianjin, Tianjin, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital ，Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China