A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
NCT ID: NCT06019936
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2023-08-10
2025-10-10
Brief Summary
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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
Detailed Description
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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 whole study will be divied to three stages including screening period (14 Days before the treatment), treatment period (the participants will be randomized to receive MT2004, or placebo orally (BID), for 12 weeks) and follow-up period. The study aims to recruit total of 80 subjects with Cholestatic and Mixed DILI, in which 12 of subjects will be firstly enrolled and allocated to the MT2004 group (Dose level: 25mg) as well as control group with the proportion of 2:1 by using the stratified randomization method. During the whole study, the adjustment of the subjects amount, the dose level as well as randomization proportion will based on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
The placebo will be used in this study, and the researchers will compare the placebo and test article to see the safety and efficacy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MT2004 Capsule
The MT2004 Capsule will be orally used twice daily after meal for 12 weeks.
MT2004 Capsule
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
MT2004 Capsule Placebo
The MT2004 Capsule Placebo will be orally used twice daily after meal for 12 weeks.
MT2004 Capsule Placebo
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 Capsule Placebo (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
Interventions
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MT2004 Capsule
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
MT2004 Capsule Placebo
The stratified randomization method will be used in this study. In treatment period, the participants will orally receive the MT2004 Capsule Placebo (BID) for 12 weeks with the dose level of 25mg. The adjustment of the dose level will base on the decesion of Independent Data Monitoring Board (IDMC). The highest dose will not exceed the 50mg BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 months.
8\. The female with fertility must have had a negative pregnancy test results before being enrolled, or at least 1 year after pausimenia, or permanent sterilization ≥6 weeks（There should have a recording of hysterectomy, bilateral salpingo-oophorectomy）. The female and their male partners with the fertility potential agree to utilize the effective contraceptive methods（the following two methods can be selected: 1. any of the condom, diaphragm, Sponge or Cervical Cap with with Spermicide ）.
9\. Fully understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.
Exclusion Criteria
2\. The history of liver decompensation or portal hypertension history
3\. Moderate or above renal insufficiency, creatinine clearance (Ccr) \< 60mL/min (according to the MDRD formula).
4\. Patients with serious diabetes and had poor control of blood sugar (HbA1c\>10%)
5\. Serious sysmetic diseases of cardiovascular, respiratory, neurological, urinary, digestive, and for any reason which, in the opinion of the Investigator think the subject is not suitable for participating in the study.
6\. The predict survival period \< 6 months.
7\. Utilization of Perursodeoxycholic acid within 14 days before the treatment.
8\. Utilization of S-adenosylmethionine within 1 days before the treatment.
9\. The patients must regularly utilize the known strong CYP3A4/3A5 inhibitors such as Clarithromycin, Itraconazole, ketoconazole, Ritonavir, rifampicin, phenytoin, carbamazepine within 1 week before the treatment or for the whole study period.
10\. Allergies or intolerances to study drug ingredients
11\. Patients are under the gestation, lactation, or patients have the pregnancy planning during the study period and 90 days after the end of the clinical trial
12\. Patients are not willing to ban the alcohol during the study period.
13\. Patients had joined the other clinical trials within 3 months before the administration.
14\. Other conditions that the investigator think the subject is not suitable for participating in the study.
18 Years
75 Years
ALL
No
Sponsors
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Xi'An Aolitai Pharmaceutical Technology Co Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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YiMin Mao, Master
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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YiMin Mao, Master
Role: primary
Other Identifiers
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CTR20232066
Identifier Type: OTHER
Identifier Source: secondary_id
MT2004-II-C01
Identifier Type: -
Identifier Source: org_study_id