ThrombocytopeniaPhase 4NCT05382013
Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
A Phase 4 study testing Avatrombopag, Artificial Liver Support System and Comprehensive internal medical treatment. in people with Thrombocytopenia and Hepatitis B, Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thrombocytopenia, Hepatitis B, Chronic, Acute-On-Chronic Liver Failure
- What is being tested?
- Avatrombopag, Artificial Liver Support System and Comprehensive internal medical treatment.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2022to 30 Apr 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Patients with ALSS treatment in one week;
- Thrombotic disease;
- Patients can not follow-up;
- Investigator considering inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: 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
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.
Read the detailed description
Artificial liver support system (ALSS) is an optimal therapy in patients with hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF). But a lot of patients encount thrombocytopenia (TCP) due to the mechanical damage of thrombocyte and use of heparin during the treatment. Avatrombopag is an oral thrombopoietin receptor agonist that has been recently approved for treating TCP in chronic liver disease patients needing invasive procedures. Therefore, this study aims to investigate the efficacy and safety of avatrombopag for treating TCP in HBV related ACLF patients receiving ALSS treatment. Sixty patients with HBV related ACLF receiving ALSS will be enrolled in this study. The participants are divided into trial group (avatrombopag, double plasma molecular adsorption system (DPMAS) , low volume plasma exchange (LPE), and comprehensive internal medical treatment) and control group (DPMAS, LPE, comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 3 weeks.
- Being tested
- Avatrombopag, Artificial Liver Support System, Comprehensive internal medical treatment.
- Keywords
- thrombocytopenia, hepatitis B virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange, artificial liver support system
- Medical subject headings
- Thrombocytopenia, Hepatitis B, Chronic, Acute-On-Chronic Liver Failure, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days
Artificial Liver Support SystemOther
Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times. The volume of plasma adsorption in DPMAS is 5000~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
Comprehensive internal medical treatment.Other
Patients will receive comprehensive internal medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | 30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment. Receives: Drug: Avatrombopag; Other: Artificial Liver Support System; Other: Comprehensive internal medical treatment. |
| Control Group | Active comparator | 30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment. Receives: Other: Artificial Liver Support System; Other: Comprehensive internal medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of platelet ≥50*10E9/L
Rate of patients with platelet ≥50*10E9/L during ALSS treatment
Measured: 3 weeks
Secondary outcomes (1)
Rate of bleeding
Incident rate of patients with bleeding during treatment
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start27 Apr 2022
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382013
- Sponsor's protocol ID
- PL16
- Status last verified
- Nov 2022
- First submitted
- 14 May 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05382013
- Acronym / sponsor ID
- PL16
- Keywords
- thrombocytopenia, hepatitis B virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange, artificial liver support system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 19 May 2022 (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.
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.
Detailed description
Artificial liver support system (ALSS) is an optimal therapy in patients with hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF). But a lot of patients encount thrombocytopenia (TCP) due to the mechanical damage of thrombocyte and use of heparin during the treatment. Avatrombopag is an oral thrombopoietin receptor agonist that has been recently approved for treating TCP in chronic liver disease patients needing invasive procedures. Therefore, this study aims to investigate the efficacy and safety of avatrombopag for treating TCP in HBV related ACLF patients receiving ALSS treatment. Sixty patients with HBV related ACLF receiving ALSS will be enrolled in this study. The participants are divided into trial group (avatrombopag, double plasma molecular adsorption system (DPMAS) , low volume plasma exchange (LPE), and comprehensive internal medical treatment) and control group (DPMAS, LPE, comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 3 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Drug: Avatrombopag, Other: Artificial Liver Support System, Other: Comprehensive internal medical treatment.30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment. |
| Control Group | Active comparator | Other: Artificial Liver Support System, Other: Comprehensive internal medical treatment.30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| AvatrombopagPatients will receive treatment of oral avatrombopag 20mg per day for the first 5 days | Drug | Trial Group |
| Artificial Liver Support SystemPatients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times. The volume of plasma adsorption in DPMAS is 5000~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre. | Other | Control Group, Trial Group |
| Comprehensive internal medical treatment.Patients will receive comprehensive internal medical treatment. | Other | Control Group, Trial Group |
Primary outcome
Rate of platelet ≥50*10E9/L
Time frame: 3 weeks
Rate of patients with platelet ≥50*10E9/L during ALSS treatment
1 secondary outcome
Rate of bleeding
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Yes. The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.
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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.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avatrombopag, Artificial Liver Support System and Comprehensive internal medical treatment. in people with Thrombocytopenia and Hepatitis B, Chronic, run by Third Affiliated Hospital, 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenxiong Xu, Doctor (+8613760783281, xwx1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of platelet ≥50*10E9/L (time frame: 3 weeks). 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 10 Nov 2022.