Status:
NOT_YET_RECRUITING
Chinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients
Lead Sponsor:
Shenzhen Third People's Hospital
Collaborating Sponsors:
Guangzhou 8th People's Hospital
Shenzhen Zhongke Amshenn Pharmaceutical Co., Ltd.
Conditions:
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
\*\*Document Name: This Trial is a Phase II Clinical Study.docx\*\* \*\*Document Content:\*\* * This trial is a Phase II clinical study, conducted in two stages: * \*\*Phase IIa:\*\* A sentinel, sing...
Eligibility Criteria
Inclusion
- The age range for signing the informed consent form is between 18 and 75 years old
- According to the "Diagnosis and Treatment Guidelines for Liver Failure (2018 Edition)" issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese Medical Association and the Severe Liver Disease and Artificial Liver Group of the Hepatology Branch of the Chinese Medical Association, it has been diagnosed with chronic acute liver failure, with specific indicators including:
- Patients with chronic liver disease (chronic hepatitis B, autoimmune hepatitis, drug-induced hepatitis, etc.) and the acute attack factor is drugs;
- Serum TBil ≥ 10 × ULN or average daily increase ≥ 17.1 μ mol/L;
- Meet any of the following three criteria: A has a tendency to bleed, PTA ≤ 40% (or INR ≥ 1.5); B combined with hepatic encephalopathy; C combined with hepatorenal syndrome or ascites.
- Screening was conducted in the early stage of liver failure and did not meet the criteria for liver transplantation;
- Early manifestations of liver failure:
- Extreme fatigue, accompanied by severe gastrointestinal symptoms such as anorexia, vomiting, and bloating; ALT and/or AST continue to significantly increase, and jaundice progressively deepens (TBil\>171 μ mol/L or daily increase\>17.1 μ mol/L); There is a tendency for bleeding, with 30%\<PTA ≤ 40% (or 1.5 ≤ INR\<1.9); No complications or other extrahepatic organ failure.
- During the screening period, serum TRAIL levels increased and were ≥ 3 times higher than normal human TRAIL levels;
- Can understand the informed consent form, voluntarily participate and sign the informed consent form;
- Capable of completing experiments in accordance with the research protocol;
- The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures within 6 months after the last administration of the investigational drug.
Exclusion
- Patients with a history of allergies or severe allergies to protein drugs (CTCAE v5.0 score\>grade 3);
- Patients who have completed liver transplantation or plan to undergo liver transplantation within one month.
- ACLF patients in the middle and late stages; Severe grade III ascites or refractory ascites accompanied by stage III-IV hepatic encephalopathy.
- Individuals who have received artificial liver treatment within one week prior to screening.
- Individuals with malignant tumors or a history of malignant tumors in the past; Patients with lung cancer, liver cancer, pancreatic cancer, gastrointestinal tract and other tumors were diagnosed by imaging (ultrasound, CT or MRI) and tumor markers (AFP, CEA, CA125 or CA199, etc.) during the screening period or within one month before the screening period.
- Individuals who have undergone gastroscopy or imaging (abdominal B-ultrasound, CT, or MRI) during the screening period or within one month prior to screening, and whose results indicate a risk of severe varicose veins with bleeding.
- Subjects with acute kidney injury (AKI) defined by KDIGO criteria: (1) Scr elevation ≥ 26.5 μ mol/L (0.3mg/dL, 1mg/dL=88.4 μ mol/L) within 48 hours; (2) Scr increases by 1.5 times or more than the baseline value within 7 days; (3) Decreased urine output (\<0.5ml/kg/h) and lasting for more than 6 hours.
- There are the following laboratory test values or abnormal test values: a. Blood routine: platelet count (PLT)\<75 × 109/L, hemoglobin (HGB)\<80g/L; b. PT-INR\>1.9 or PTA\<30%; c. Left ventricular ejection fraction (LVEF)\<50%; Blood creatinine\>1.5 × ULN.
- Patients with severe respiratory dysfunction, difficulty breathing, or failure.
- Severe infections that cannot be controlled by concomitant medications, including infections of major organs such as the abdominal cavity, lungs, urinary tract, and skin.
- HIV positive individuals, or active tuberculosis or syphilis infected individuals.
- Individuals with a history of unstable ischemic heart disease, congestive heart failure, myocardial infarction, stroke, severe arrhythmia, etc.
- Subjects with uncontrolled severe hypertension or diabetes.
- Pregnant or lactating women, or those who test positive for pregnancy.
- Participants in clinical trials of other drugs or medical devices within 30 days prior to randomization or within five drug half lives.
- Having undergone trauma or major surgery (e.g. requiring general anesthesia) within 28 days prior to the first administration of the investigational drug. Note: Participants who plan to undergo surgical procedures under local anesthesia are eligible to participate in the study.
- Any serious underlying medical or mental condition (such as alcohol or drug abuse), dementia, or change in mental state; Or any issues that may impair the subject's ability to receive or tolerate planned treatment at the research center, understand informed consent, or issues that the researcher deems taboo to participate in the study or confound the evaluation or study results specified in the protocol.
- Researchers believe that other conditions are not suitable for participating in this study.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06916585
Start Date
April 15 2025
End Date
December 31 2027
Last Update
April 9 2025
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