NCT04195282

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 8, 2019

Last Update Submit

December 10, 2019

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Keywords

hepatitis b virusacute-on-chronic liver failureartificial liver

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.

    4 week

Secondary Outcomes (8)

  • Survival rate

    4 week

  • Symptoms

    4 week

  • Blood cells

    4 week

  • Alanine transaminase

    4 week

  • Total bilirubin

    4 week

  • +3 more secondary outcomes

Study Arms (2)

Plasma exchange group

ACTIVE COMPARATOR

10 patients will receive conventional treatment plus plasma exchange

Other: Plasma exchange

RL-1 Novel Human-derived Bio-artificial Liver treatment group

EXPERIMENTAL

10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment

Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment

Interventions

Plasma exchangeOTHER

Patients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time.

Plasma exchange group
RL-1 Novel Human-derived Bio-artificial Liver TreatmentOTHER

Patients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time.

RL-1 Novel Human-derived Bio-artificial Liver treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Investigator considering inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesLiver Failure, AcuteLiver FailureHepatic Insufficiency

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Liang Peng, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874pzp33@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 11, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

CN(1)