The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatmen… (NCT02944552) | Clinical Trial Compass
CompletedPhase 2
The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI
China244 participantsStarted 2017-08-18
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18-75 years old, male or female;
✓. 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;
✓. The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
✓. Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less than 90 days;
✓. 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
✕. Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
✕. 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;
✕. Serum creatinine is more than 1.5 times ULN;
✕. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
✕. Taking drugs that may affect observation of curative effect of the experimental drug during the study;
What they're measuring
1
The decline range of serum ALT after 4 weeks of treatment