UnknownPhase 4

Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment

China60 participantsStarted 2022-04-27

Plain-language summary

This study aims to investigate the efficacy and safety of avatrombopag for treating thrombocytopenia in hepatitis b virus related acute-on-chronic liver failure patients receiving artificial liver support system treatment.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 liver failure (serum total bilirubin level \> 10 times upper limit of normal; prothrombin time activity \< 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \> 1.5);
✓. Platelets \< 80\*10 E9/L and \> 50\*10 E9/L.
✓. Signed informed consent form.

Exclusion criteria

✕. Other active liver diseases;
✕. Hepatocellular carcinoma or 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;
✕. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
✕. Patients with ALSS treatment in one week;
✕. Thrombotic disease;

What they're measuring

Rate of platelet ≥50*10E9/L

Timeframe: 3 weeks

Trial details

NCT IDNCT05382013

SponsorThird Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-29

Contact for this trial

Wenxiong Xu, Doctor

+8613760783281 xwx1983@163.com

View on ClinicalTrials.gov More Thrombocytopenia trials