Liver FailureNCT03082885
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
A study testing Thymosin-α1 in people with Liver Failure, run by Sun Yat-sen University at 1 site in China.
Trial summary
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- Thymosin-α1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
- 2.Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
- 3.Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
- 4.Development of coagulopathy(PTA≤40% or INR≥1.5 ).
- More than one of the 5-8 criteria：
- 5.Development of hepatic encephalopathy.
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- 6.Development of hepatorenal syndrome.
- 7.Hepatic narrowing progressively.
- 8.Development of massive ascites or peritonitis.
- 9. Willing to provide informed consent and comply with the test requirements
Who cannot join
- 1.Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
- 2.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.
- 3.Model for end-stage liver disease (MELD) score <17 or >35.
- 4.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.
- 5.Patients with diseases that researchers consider inappropriate to participate in the study.
- 6.Patients who have disseminated intravascular coagulation.
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- 7.Drug allergy.
- 8.Patients with any other contraindications to thymosin alpha1.
- 9.Patients who participated in other clinical trials at the same time.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Read the detailed description
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, the investigators intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
- Conditions
- Liver Failure
- Being tested
- Thymosin-α1
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin-α1Drug
Also called Zadaxin
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.
| Study group | Role | What they receive |
|---|---|---|
| Thymosin-α1 group | Experimental | Patients receive treatment based on standard Therapy with additional Thymosin-α1 Receives: Drug: Thymosin-α1 |
| control group | No intervention | Patients receive treatment based on standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The liver transplantation-free survival rate of 90 days
Survival condition of the patients were observed for 90 days
Measured: 90 days
Secondary outcomes (11)
The liver transplantation-free survival rate of 180 days
Survival condition of the patients were observed for 180 days
Measured: 180 days
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
Fever, bleeeding of injection site, amyotrophy and arthralgia were observed during the treatment in both group.
Measured: 24 weeks
Complications after 48 hours admission
Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
Measured: 24 weeks
Hepatitis B virus DNA load change
Hepatitis B virus DNA were measured on week 0, 4,8,12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Causes of death/liver transplantation
Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
Measured: 24 weeks
Inflammatory indexes change
Inflammatory indexes were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Alanine aminotransferase change
Levels of alanine aminotransferase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Glutamic oxaloacetic transaminase change
Levels of glutamic oxaloacetic transaminase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Total bilirubin change
Levels of total bilirubin were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Plasma thrombin time change
Levels of plasma thrombin time were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Albumin time change
Levels of albumin were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start10 Apr 2017
- Primary completion2 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Bingliang, Sun Yat-sen University
- Investigators
- Lin B Liang, MD, Principal investigator, leading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082885
- Sponsor's protocol ID
- Thymosin-α1
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2017
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT03082885
- Acronym / sponsor ID
- Thymosin-α1
- Conditions
- Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Detailed description
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, the investigators intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymosin-α1 group | Experimental | Drug: Thymosin-α1Patients receive treatment based on standard Therapy with additional Thymosin-α1 |
| control group | No intervention | –Patients receive treatment based on standard Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
- 2.Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
- 3.Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
- 4.Development of coagulopathy(PTA≤40% or INR≥1.5 ).
- More than one of the 5-8 criteria：
Key exclusion criteria (9 listed)
- 1.Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
- 2.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.
- 3.Model for end-stage liver disease (MELD) score <17 or >35.
- 4.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.
- 5.Patients with diseases that researchers consider inappropriate to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin-α1Also: Zadaxin1.6 mg s.c injection once per day for 7 days, then 1.6 mg s.c injection twice a week for 11 weeks. | Drug | Thymosin-α1 group |
Primary outcome
The liver transplantation-free survival rate of 90 days
Time frame: 90 days
Survival condition of the patients were observed for 90 days
11 secondary outcomes
The liver transplantation-free survival rate of 180 days
Time frame: 180 days
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
Time frame: 24 weeks
Complications after 48 hours admission
Time frame: 24 weeks
Hepatitis B virus DNA load change
Time frame: 24 weeks
Causes of death/liver transplantation
Time frame: 24 weeks
Inflammatory indexes change
Time frame: 24 weeks
Alanine aminotransferase change
Time frame: 24 weeks
Glutamic oxaloacetic transaminase change
Time frame: 24 weeks
Total bilirubin change
Time frame: 24 weeks
Plasma thrombin time change
Time frame: 24 weeks
Albumin time change
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin B Liang, MD principal investigator
leading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymosin-α1 in people with Liver Failure, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The liver transplantation-free survival rate of 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.