A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

NCT06019936 | Unknown Phase 2 FDA Drug

• 2 other identifiers: MT2004-II-C01CTR20232066
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 induced liver injury (DILI) subjects. The main questions it aims to answer are:

1. 1.The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects
2. 2.The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects
3. 3.The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects

Conditions

Drug-Induced Liver Injury; Cholestatic Liver Injury; Mixed Liver Injury

Keywords

Drug-Induced Liver Injury

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint

  The efficacy of MT2004 will be evaluated based on the decreasing rate on serum ALP compared to baseline.

  On the week 4 after the administration

Secondary Outcomes (13)

• Secondary efficacy endpoint

  On the week 2,8,12 after the administration and the week 4 follow-up period

• Secondary efficacy endpoint

  On the week 2,4,8,12 after the administration and the week 4 follow-up period

• Secondary efficacy endpoint

  On the week 2,4,8,12 after the administration and the week 4 follow-up period

• Secondary efficacy endpoint

  On the week 2,4,8,12 after the administration and the week 4 follow-up period

• Secondary efficacy endpoint

  On the week 2,4,8,12 after the administration and the week 4 follow-up period

Other Outcomes (1)

• Safety endpoint

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 12 weeks.

Study Arms (2)

MT2004 Capsule

EXPERIMENTAL

The MT2004 Capsule will be orally used twice daily after meal for 12 weeks.

Drug: MT2004 Capsule

MT2004 Capsule Placebo

PLACEBO COMPARATOR

The MT2004 Capsule Placebo will be orally used twice daily after meal for 12 weeks.

Drug: MT2004 Capsule Placebo

Interventions

MT2004 Capsule DRUG

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.

Also known as: MT2004

MT2004 Capsule

MT2004 Capsule Placebo DRUG

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.

MT2004 Capsule Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18≤ age ≤ 75 years, male or female.
• \. 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.
• \. 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).
• \. 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)
• \. 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.
• \. 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).
• \. The duration of this liver injury is less than 6 months.
• \. 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 ）.
• \. Fully understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.

You may not qualify if:

• \. Acute or chronic liver failure or liver decompensation
• \. The history of liver decompensation or portal hypertension history
• \. Moderate or above renal insufficiency, creatinine clearance (Ccr) \< 60mL/min (according to the MDRD formula).
• \. Patients with serious diabetes and had poor control of blood sugar (HbA1c\>10%)
• \. 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.
• \. The predict survival period \< 6 months.
• \. Utilization of Perursodeoxycholic acid within 14 days before the treatment.
• \. Utilization of S-adenosylmethionine within 1 days before the treatment.
• \. 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.
• \. Allergies or intolerances to study drug ingredients
• \. 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
• \. Patients are not willing to ban the alcohol during the study period.
• \. Patients had joined the other clinical trials within 3 months before the administration.
• \. Other conditions that the investigator think the subject is not suitable for participating in the study.

Sponsors & Collaborators

• Xi'An Aolitai Pharmaceutical Technology Co Ltd: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine,Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• YiMin Mao, Master

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LanLan Song, Master

CONTACT

+8615929300901; songlanlan@micot.cn

DeChuang Yuan, Master

CONTACT

yuandechuang@micot.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blinded for MT2004/matching placebo. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (MT2004 or placebo).Blinding will be maintained until at least the clinical phase of the study is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: August 10, 2023
• Primary Completion: August 10, 2025
• Study Completion: October 10, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)