Status:
UNKNOWN
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
Lead Sponsor:
Xi'An Aolitai Pharmaceutical Technology Co Ltd
Conditions:
Drug-Induced Liver Injury
Cholestatic Liver Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 indu...
Detailed Description
Xi'An Aolitai Pharmaceutical Technology Co Ltd is developing MT2004, a novel investigational synthetic small molecule farnesoid X receptor (FXR) agonist targeted to the liver. The MT2004 was designed ...
Eligibility Criteria
Inclusion
- 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 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
- 1\. Acute or chronic liver failure or liver decompensation
- 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.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06019936
Start Date
August 10 2023
End Date
October 10 2025
Last Update
August 31 2023
Active Locations (1)
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1
Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, China, 200001