UnknownNot Applicable

RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF

China20 participantsStarted 2019-12

Plain-language summary

This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
✓. Age from 18 to 65 years old;
✓. Serum total bilirubin level \> 10 times upper limit of normal;
✓. Prothrombin time activity \< 40% and ≥30%；
✓. Platelets \> 50\*10 E9/L.

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;
✕. Other important organ dysfunctions;
✕. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
✕. Patients can not follow-up;

What they're measuring

Adverse events

Timeframe: 4 week

Trial details

NCT IDNCT04195282

SponsorThird Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Contact for this trial

Wenxiong Xu, Doctor

+8613760783281 xwx1983@163.com

View on ClinicalTrials.gov More Hepatitis B trials