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Tests treatment safety and results for Immune-Mediated Hepatitis
Official title Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
ClinicalTrials.gov ID: NCT05484908
What this study is testing
- What it's testing
- This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.
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 65
You may be able to join if
- Age from 18 to 65 years old;
- Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
- Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors...
- The level of hepatitis b virus DNA \< 2000 IU/mL；
- Serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal；
You likely can't join if
- Other active liver diseases;
- Other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
- Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
See the full eligibility criteria
- Age from 18 to 65 years old;
- Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
- Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;
- The level of hepatitis b virus DNA \< 2000 IU/mL；
- Serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal；
- Prothrombin time international ratio \> 1.5;
- Platelets \> 50\ 10 E9/L;
- Without intrahepatic bile duct dilation due to tumor progression.
- Other active liver diseases;
- Other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
- Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
- Patients received artificial liver support system treatment in one week before inclusion;
- Patients can not follow-up;
- Investigator considering inappropriate
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.