Liver FailurePhase 4NCT04906083
Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia
A Phase 4 study testing Avatrombopag and Standard medical treatment in people with Liver Failure and Thrombocytopenia, run by Tongji Hospital at 1 site in China.
Trial summary
End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Thrombocytopenia, Decompensated Cirrhosis
- What is being tested?
- Avatrombopag and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women greater than or equal to 18 years of age;
- Baseline platelet count <50×10^9/L;
- End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;
- Women of childbearing potential must agree to use a highly effective method of contraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combination contraception [including vaginal rings], intra-uterine devices or vasectomy). The barrier contraception with or without spermicide alone, double barrier contraception and oral contraceptives are inadequate;
- Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;
- Subject meet the criteria according to the opinion of the researchers.
Who cannot join
- Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;
- Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;
- Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
- Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);
- Subject has a recent history (within the previous 6 months) of significant cardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [e.g. atrial fibrillation], coronary or peripheral artery stent placement or angioplasty, and coronary or peripheral artery bypass grafting);
- Female subjects who are lactating or pregnant at the Baseline Visit (as documented by a positive serum beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to become pregnant during the study;
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- The subject has a hypersensitivity to Avatrombopag or any of its excipients;
- Subjects with drug-induced thrombocytopenia;
- Subjects whose Life expectation ≤6 months;
- Subject with a current malignancy;
- Subjects with HIV infection;
- At screening, active infection was not effectively controlled by systemic antibiotic therapy;
- The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study;
- The Investigator believe that there are any other factors that are not suitable for inclusion or affect participation or completion of the study;
- Subject is enrolled in another clinical study with any investigational drug or device within previous 30 days of the Baseline Visit, but are allowed to participate in observational studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of infectious disease, Tongji Hospital
Wuhan, Hubei, 430030
Qin Ning, +8602783662391, qning@vip.sina.com
About this study
Official title: The Efficacy and Safety of Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia: A Multicenter, Prospective, Randomized Controlled Trial（EAST）
End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.
Read the detailed description
End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50~100×10^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.
- Conditions
- Liver Failure, Thrombocytopenia, Decompensated Cirrhosis
- Being tested
- Avatrombopag, Standard medical treatment
- Keywords
- end-stage liver disease, thrombocytopenia, avatrombopag, efficacy, safety
- Medical subject headings
- Liver Failure, Thrombocytopenia, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Avatrombopag:
PLT：30~50×10^9/L patients, 40 mg/d; PLT：<30×10^9/L patients, 60 mg/d.
Standard medical treatmentDrug
Also called transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.
Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Avatrombopag+Standard medical treatment Receives: Drug: Avatrombopag; Drug: Standard medical treatment |
| Control group | Other | Standard medical treatment Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count response time
Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.
Measured: 24 weeks
Secondary outcomes (9)
Adverse Event (thrombotic events, bleeding events, etc.) incidence;
Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks
Measured: 24 weeks
Incidence of complications of liver cirrhosis (infection, etc.)
Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks
Measured: 24 weeks
Patients without platelet transfusion or rescue due to bleeding
Patients without platelet transfusion or rescue due to bleeding refers to the patients rate without platelet transfusion or rescue due to bleeding between the two groups at 24 week
Measured: 24 weeks
Proportion of patients readmitted
Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group
Measured: 24 weeks
Changes in total bilirubin level
Changes in total bilirubin level refers to the changes of total bilirubin at 24 week compared to baseline between the Intervention group and Control group.
Measured: 24 weeks
Changes in alanine aminotransferase level
Changes in alanine aminotransferase level refers to the changes of alanine aminotransferase at 24 week compared to baseline between the Intervention group and Control group.
Measured: 24 weeks
Changes in albumin level
Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group.
Measured: 24 weeks
Changes in prothrombin time level
Changes in prothrombin time level refers to the changes of prothrombin time at 24 week compared to baseline between the Intervention group and Control group.
Measured: 24 weeks
Changes in international normalized ratio level
Changes in international normalized ratio level refers to the changes of international normalized ratio at 24 week compared to baseline between the Intervention group and Control group.
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 posted28 May 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Tongji HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital, The First Affiliated Hospital of Nanchang University, Taihe Hospital, Hubei University of Medicine, The First Hospital of Jilin University
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, MD., PhD., Study chair, Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906083
- Sponsor's protocol ID
- TJ20210517
- Status last verified
- Jun 2021
- First submitted
- 17 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia: A Multicenter, Prospective, Randomized Controlled Trial（EAST）
- ClinicalTrials.gov ID
- NCT04906083
- Acronym / sponsor ID
- TJ20210517
- Conditions
- Liver Failure, Thrombocytopenia, Decompensated Cirrhosis
- Keywords
- end-stage liver disease, thrombocytopenia, avatrombopag, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital, The First Affiliated Hospital of Nanchang University, Taihe Hospital, Hubei University of Medicine, The First Hospital of Jilin University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 May 2021 (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.
End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.
Detailed description
End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50~100×10^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Avatrombopag, Drug: Standard medical treatmentAvatrombopag+Standard medical treatment |
| Control group | Other | Drug: Standard medical treatmentStandard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women greater than or equal to 18 years of age;
- Baseline platelet count <50×10^9/L;
- End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;
- Women of childbearing potential must agree to use a highly effective method of contraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combination contraception [including vaginal rings], intra-uterine devices or vasectomy). The barrier contraception with or without spermicide alone, double barrier contraception and oral contraceptives are inadequate;
- Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;
Key exclusion criteria (15 listed)
- Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;
- Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;
- Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
- Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);
- Subject has a recent history (within the previous 6 months) of significant cardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [e.g. atrial fibrillation], coronary or peripheral artery stent placement or angioplasty, and coronary or peripheral artery bypass grafting);
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 |
|---|---|---|
| AvatrombopagAvatrombopag: PLT：30~50×10^9/L patients, 40 mg/d; PLT：<30×10^9/L patients, 60 mg/d. | Drug | Intervention group |
| Standard medical treatmentAlso: transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al. | Drug | Control group, Intervention group |
Primary outcome
Platelet count response time
Time frame: 24 weeks
Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.
9 secondary outcomes
Adverse Event (thrombotic events, bleeding events, etc.) incidence;
Time frame: 24 weeks
Incidence of complications of liver cirrhosis (infection, etc.)
Time frame: 24 weeks
Patients without platelet transfusion or rescue due to bleeding
Time frame: 24 weeks
Proportion of patients readmitted
Time frame: 24 weeks
Changes in total bilirubin level
Time frame: 24 weeks
Changes in alanine aminotransferase level
Time frame: 24 weeks
Changes in albumin level
Time frame: 24 weeks
Changes in prothrombin time level
Time frame: 24 weeks
Changes in international normalized ratio level
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Qin Ning, MD., PhD. study chair
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
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 and Standard medical treatment in people with Liver Failure and Thrombocytopenia, run by Tongji Hospital 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 6 inclusion and 15 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 7 Jun 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.
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 Qin Ning, MD., PhD. (+8602783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count response time (time frame: 24 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 7 Jun 2021.