Drug-Induced Acute Liver Injury
Conditions
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.
Interventions
DRUGbicyclol tablet 25mg
Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
DRUGbicyclol tablet 50mg
Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
DRUGpolyene phosphatidylcholine capsule 456mg
Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
Sponsors
Beijing Union Pharmaceutical Factory Ltd
Drug Induced Liver Disease Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18-75 years old, male or female; 2. Meet the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3-5,the subject needs three liver disease experts to confirm whether he is DILI patient, at least two of three liver disease experts should have the same judgment; 3. The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN; 4. Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less than 90 days; 5. Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods and the risk they may need to bear if they participate in the test, and sign the informed consent.
Exclusion criteria
1. Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc; 2. Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, ascites, albumin is less than or equal to 35g / L, The international standardized ratio (INR) of thrombin is more than 1.5; 3. Serum creatinine is more than 1.5 times ULN; 4. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases; 5. Taking drugs that may affect observation of curative effect of the experimental drug during the study; 6. Allergy or intolerance to experimental drugs; 7. With no ability to express their complaints, such as mental illness and severe neurosis patient; 8. The patient can not cooperate and poor compliance; 9. Pregnant and lactating women or women preparing for pregnancy; 10. The patient participated in other clinical trials in 3 months before entering this study; 11. Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within three days; 12. The researchers believe not suitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
Countries
China
Outcome results
None listed