The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Recruiting
Phase 3
Interventional Study
Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 101 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial
This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytop…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
2. Platelet count less than 50×10\^9/L on baseline;
3. Elective invasive procedures or surgeries that are planned.
Exclusion Criteria:
1. Any history of arterial or venous thrombosis, in…
Contacts