A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Effic… (NCT06019936) | Clinical Trial Compass
UnknownPhase 2
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
China80 participantsStarted 2023-08-10
Plain-language summary
The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI) subjects.
The main questions it aims to answer are:
1. The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects
2. The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects
3. The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\. 18≤ age ≤ 75 years, male or female.
2\. When diagnosis of acute DILI, the liver biochemical threshold of patients must meet one of the following criteria: :(1) ALT ≥5 ×ULN;(2) ALP ≥2× ULN;(3) ALT≥3× ULN and TBil ≥2×ULN.
3\. ALP ≥2× ULN, and conform to the clinical classification of cholestatic type or mixed type DILI in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition) (cholestatic type: R value ≤2; Mixed type: 2\<R value \<5).
4\. Excluded other common causes of acute liver injury, such as acute viral hepatitis A, B, C, E, autoimmune hepatitis, biliary tract disease, PBC, etc. (Exclusive diagnostic tests completed in our hospital or other hospitals after this suspected acute DILI event or within 2 months before screening were acceptable)
5\. RUCAM causality scale score ≥6 points; If the RUCAM score is between the 3-5 it is necessary to evaluate the causal relationship by three experts according to the evaluation criteria of expert opinions in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition), and at least two experts determine that the liver injury of the patients are "likely", "very likely" or "definitely" caused by drugs.
6\. The serious level of DILI is within level 1-2 based on the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition).
7\. The duration of this liver injury is less than 6 mo…
What they're measuring
1
Primary efficacy endpoint
Timeframe: On the week 4 after the administration
Trial details
NCT IDNCT06019936
SponsorXi'An Aolitai Pharmaceutical Technology Co Ltd