BridgeMD
New treatment option for Acute-On-Chronic Liver Failure
Official title Chinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients
ClinicalTrials.gov ID: NCT06916585
What this study is testing
What is AS1501 for injection?
AS1501 for injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for acute-on-chronic liver failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- \ \ 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, single-arm design will be employed. A total of 12 early ACLF subjects are expected to be enrolled in the 0.5 mg/kg dose group.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Stage IIa - Main 1. The age of the signatories to the informed consent form must range from 18 to 75 years old (including the boundary values).
- During screening, chronic plus acute liver failure was diagnosed based on the Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)...
- During the screening phase, serum TRAIL levels are elevated to ≥2 times that of normal individuals, or NK cell membrane-type TRAIL expression is...
- Can comprehend the informed consent form, voluntarily participate in it, and sign it;
- Capable of completing the trial in accordance with the study protocol;
You likely can't join if
- Patients with a history of allergic predisposition or severe hypersensitivity to protein-based drugs (CTCAE v5.0 grade\>3);
- Patients who have undergone liver transplantation or plan to undergo liver transplantation within 1 month;
- ACLF patients at intermediate or advanced stages;
- Severe Grade III ascites or refractory ascites;
- Associated with stage III-IV hepatic encephalopathy;
- Patients with concurrent malignant tumors or a history of malignant tumors; those diagnosed with lung cancer, liver cancer, pancreatic cancer, or...
See the full eligibility criteria
Who can join
- Stage IIa - Main 1. The age of the signatories to the informed consent form must range from 18 to 75 years old (including the boundary values).
- During screening, chronic plus acute liver failure was diagnosed based on the Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition) issued by the Liver Failure and Artificial Liver Group of the...
- During the screening phase, serum TRAIL levels are elevated to ≥2 times that of normal individuals, or NK cell membrane-type TRAIL expression is increased.
- Can comprehend the informed consent form, voluntarily participate in it, and sign it;
- Capable of completing the trial in accordance with the study protocol;
- Participants (including their partners) are willing to voluntarily adopt effective contraceptive measures from the screening stage through 6 months after the last administration of the investigational drug. Stage IIb -...
- The age of the signatories to the informed consent form must range from 18 to 75 years old (including the boundary values).
- The screening criteria were based on the "Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)" issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese...
- During the screening phase, serum TRAIL levels are elevated to ≥2 times that of normal individuals, or NK cell membrane-type TRAIL expression is increased.
- Can comprehend the informed consent form, voluntarily participate in it, and sign it;
- Can comply with the study protocol and complete the trial.
- Participants (including their partners) are willing to voluntarily adopt effective contraceptive measures from the screening stage through 6 months after the last administration of the investigational drug. Stage IIa -...
What rules you out
- Patients with a history of allergic predisposition or severe hypersensitivity to protein-based drugs (CTCAE v5.0 grade\>3);
- Patients who have undergone liver transplantation or plan to undergo liver transplantation within 1 month;
- ACLF patients at intermediate or advanced stages;
- Severe Grade III ascites or refractory ascites;
- Associated with stage III-IV hepatic encephalopathy;
- Patients with concurrent malignant tumors or a history of malignant tumors; those diagnosed with lung cancer, liver cancer, pancreatic cancer, or gastrointestinal tumors through imaging studies (ultrasound, CT, or MRI)...
- Patients during the screening period or within 1 month prior to screening whose endoscopic or imaging (abdominal ultrasound, CT, or MRI) findings indicate severe varices with a bleeding risk;
- The KDIGO criteria for acute kidney injury (AKI) define the following people: (1) a serum creatinine (Scr) level increase of ≥26.5 μmol/L (0.3 mg/dL; 1 mg/dL = 88.4 μmol/L) within 48 hours; (2) a Scr increase of ≥1.5...
- The following laboratory test values are present or abnormal: a. Complete blood count: platelets (PLT) \ 1.5×ULN.
- Those with severe respiratory dysfunction, dyspnea, or respiratory 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;
- Individuals who are HIV-positive, or have active pulmonary tuberculosis or syphilis infection;
- Patients with a history of unstable ischemic heart disease, congestive heart failure, myocardial infarction (MI), stroke, severe arrhythmias, or other related conditions;
- Patients with severe hypertension or diabetes that cannot be controlled with concomitant medications;
- Women who are pregnant or breastfeeding, or those with a positive pregnancy test result;
- Individuals who participated in clinical trials involving other drugs or medical devices within 30 days prior to randomization or during any of the five drug half-life periods;
- The study people must have undergone trauma or major surgery (e.g., requiring general anesthesia) within 28 days prior to the first administration of the investigational drug. Note: people scheduled for surgical...
- Any serious potential medical or psychiatric condition (e.g., alcohol or drug abuse), dementia, or changes in mental status; or any issue that may impair the subject's ability to receive or tolerate the planned...
- The researchers identified other conditions that made participants unsuitable for this study. Stage IIb - Main exclusion criteria people are ineligible for inclusion in this study if any of the following criteria are...
- Patients with a history of allergic predisposition or severe hypersensitivity to protein-based drugs (CTCAE v5.0 grade\>3);
- Patients who have undergone liver transplantation or plan to undergo liver transplantation within 1 month;
- Patients with advanced ACLF;
- Severe Grade III ascites or refractory ascites;
- Associated with stage III-IV hepatic encephalopathy;
- Patients with concurrent malignant tumors or a history of malignant tumors; those diagnosed with lung cancer, liver cancer, pancreatic cancer, or gastrointestinal tumors through imaging studies (ultrasound, CT, or MRI)...
- Patients during the screening period or within 1 month prior to screening whose endoscopic or imaging (abdominal ultrasound, CT, or MRI) findings indicate severe varices with a bleeding risk;
- Patients with severe coagulation failure defined as PT-INR ≥ 2.6 or PTA ≤ 20%; complete blood count: platelets (PLT) \<75 × 10⁹/L, hemoglobin (HGB) \<80 g/L;
- Those with severe respiratory dysfunction, dyspnea, or respiratory 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;
- Individuals who are HIV-positive, or have active pulmonary tuberculosis or syphilis infection;
- Patients with a history of unstable ischemic heart disease, congestive heart failure, myocardial infarction (MI), stroke, severe arrhythmias, or other related conditions;
- Patients with severe hypertension or diabetes that cannot be controlled with concomitant medications;
- Women who are pregnant or breastfeeding, or those with a positive pregnancy test result;
- Individuals who participated in clinical trials involving other drugs or medical devices within 30 days prior to randomization or during any of the five drug half-life periods;
- The study people must have undergone trauma or major surgery (e.g., requiring general anesthesia) within 28 days prior to the first administration of the investigational drug. Note: people scheduled for surgical...
- Any serious potential medical or psychiatric condition (e.g., alcohol or drug abuse), dementia, or changes in mental status; or any issue that may impair the subject's ability to receive or tolerate the planned...
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.