NCT03082885

Brief Summary

A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

February 23, 2017

Last Update Submit

August 8, 2021

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

  • The liver transplantation-free survival rate of 90 days

    Survival condition of the patients were observed for 90 days

    90 days

Secondary Outcomes (11)

  • The liver transplantation-free survival rate of 180 days

    180 days

  • Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia

    24 weeks

  • Complications after 48 hours admission

    24 weeks

  • Hepatitis B virus DNA load change

    24 weeks

  • Causes of death/liver transplantation

    24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Thymosin-α1 group

EXPERIMENTAL

Patients receive treatment based on standard Therapy with additional Thymosin-α1

Drug: Thymosin-α1

control group

NO INTERVENTION

Patients receive treatment based on standard Therapy

Interventions

Thymosin-α1DRUG

1.6 mg s.c injection once per day for 7 days, then 1.6 mg s.c injection twice a week for 11 weeks.

Also known as: Zadaxin
Thymosin-α1 group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
  • Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
  • Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
  • Development of coagulopathy(PTA≤40% or INR≥1.5 ).
  • More than one of the 5-8 criteria：
  • Development of hepatic encephalopathy.
  • Development of hepatorenal syndrome.
  • Hepatic narrowing progressively.
  • Development of massive ascites or peritonitis.
  • \. Willing to provide informed consent and comply with the test requirements

You may not qualify if:

  • Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
  • Patients who have autoimmune disease (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, etc ) or with abnormal elevation level of autoimmune antibody.
  • Model for end-stage liver disease (MELD) score \<17 or \>35.
  • Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
  • Patients with diseases that researchers consider inappropriate to participate in the study.
  • Patients who have disseminated intravascular coagulation.
  • Drug allergy.
  • Patients with any other contraindications to thymosin alpha1.
  • Patients who participated in other clinical trials at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Liver Failure

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Lin B Liang, MD

    leading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 17, 2017

Study Start

April 10, 2017

Primary Completion

June 2, 2019

Study Completion

July 30, 2019

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)