Trial · Interventional
Status unknownPhase 4Registry dataAvatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 150 participants (estimated)
- Sponsor
- Tongji Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
China
- Start
- 1 Feb 2021
- Primary completion
- 31 Dec 2022 (estimated)
- Completion
- 31 Dec 2022 (estimated)
- First posted
- 28 May 2021
- Last update posted
- 7 Jun 2021
- Conditions
- Liver Failure · Thrombocytopenia · Decompensated Cirrhosis
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia
NCT049060831 Feb 2021 to est. 31 Dec 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- AvatrombopagDrug
- Standard medical treatmentDrug
Arms2
Experimental
Intervention group
Avatrombopag+Standard medical treatment
Other
Control group
Standard medical treatment
Primary outcomes1
Outcomes the sponsor listed as primary.
Platelet count response time
Time frame · 24 weeks
Registry description
Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.
Secondary outcomes(9)
Adverse Event (thrombotic events, bleeding events, etc.) incidence;
Time frame · 24 weeks
Registry description
Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks
Incidence of complications of liver cirrhosis (infection, etc.)
Time frame · 24 weeks
Registry description
Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks
Patients without platelet transfusion or rescue due to bleeding
Time frame · 24 weeks
Registry description
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
Proportion of patients readmitted
Time frame · 24 weeks
Registry description
Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group
Changes in total bilirubin level
Time frame · 24 weeks
Registry description
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.
Changes in alanine aminotransferase level
Time frame · 24 weeks
Registry description
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.
Changes in albumin level
Time frame · 24 weeks
Registry description
Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group.
Changes in prothrombin time level
Time frame · 24 weeks
Registry description
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.
Changes in international normalized ratio level
Time frame · 24 weeks
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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